Miles Laboratories, Inc.
Medical device manufacturer in Berkeley, CA.
158510(k) clearances
1PMA approvals
0recalls
Device types
- CGA Glucose Oxidase, Glucose 12
- JQP Calculator/Data Processing Module, For… 8
- KQO Automated Urinalysis System 6
- CDX Radioimmunoassay, Total Thyroxine 4
- KHG Whole Blood Hemoglobin Determination 4
- IEO Processor, Tissue, Automated 4
- LET Fluorescent Immunoassay, Phenobarbital 3
- DJB Radioimmunoassay, Gentamicin (125-I)… 3
- KLT Enzyme Immunoassay, Carbamazepine 3
- KHQ Radioassay, Triiodothyronine Uptake 3
- LER Fluorescent Immunoassay, Theophylline 3
- JJW Urinalysis Controls (Assayed And Unassayed) 3
- JIL Method, Enzymatic, Glucose (Urinary… 3
- JTY Culture Media, For Isolation Of Pathogenic… 2
- LES Fluorescent Immunoassay, Diphenylhydantoin 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- KNK Acid, Uric, Uricase (Colorimetric) 2
- KLS Enzyme Immunoassay, Theophylline 2
- CDM Diazonium Colorimetry, Urobilinogen… 2
- JIS Calibrator, Primary 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
| K864530 | Seralyzer Glucose (HK) Reagent Strips,Module,Cali.CGA · Traditional | 02/18/1987SE |
| K865020 | Sera-Tek Thyroglobulin Antibody TestDDC · Traditional | 02/02/1987SE |
| K863842 | Seralyzer Aris Carbamazepine Strips/Modu/Cali/ContKLT · Traditional | 01/14/1987SE |
| K861844 | Glucofacts Data Management SystemJQP · Traditional | 08/12/1986SE |
| K861779 | Glucofacts Data PrinterJQP · Traditional | 08/08/1986SE |
| K861778 | Clinifacts 200 Data Management SystemJQP · Traditional | 07/02/1986SE |
| K861303 | Glucometer II Improved Reflectance PhotometerCGA · Traditional | 07/02/1986SE |
| K855202 | Glucometer M Blood Gulcose MeterCGA · Traditional | 07/02/1986SE |
| K855203 | Glucolet Automatic Lancing Device for Obt. BloodFMK · Traditional | 02/11/1986SE |
| K855040 | Seralyzer Total Bilirubin CalibratorsJIS · Traditional | 01/22/1986SE |
| K852946 | Sera Aris Pheno Reag Strip, Test Mod Cal & CLTDLZ · Traditional | 09/30/1985SE |
| K852611 | Test Urobilinogen in Urine & Leukocytes in UrineCDM · Traditional | 09/03/1985SE |
| K851703 | Glucostix Reagent Strips & Glucometer Reflect-PhotCGA · Traditional | 08/23/1985SE |
| K852747 | Visidex II Reagent Strips · Traditional | 08/12/1985SE |
| K853021 | Optimate Digoxin TestDPB · Traditional | 08/07/1985SE |
| K852117 | Cyto-Tek CentrifugeIFB · Traditional | 06/10/1985SE |
| K844955 | Seralyzer Potassium Reagent Strips, Test Module, &CEM · Traditional | 03/19/1985SE |
| K842092 | Seralyzer Aris Phenytoin Reagent StripsDIP · Traditional | 03/19/1985SE |
| K844907 | Clinifacts 10 Data Management SystemJQP · Traditional | 01/18/1985SE |
| K843727 | Leukostix Reagent Strips for UrinalysisLJX · Traditional | 01/04/1985SE |
| K842470 | Tissue-Tek Immunohistology Kit LysozzmDFH · Traditional | 08/28/1984SE |
| K842468 | Tissue-Tek Immunohistology Kit Iga/IggCZP · Traditional | 08/28/1984SE |
| K841041 | Clini-Tek Auto 2000 Reflectance SpectrKQO · Traditional | 08/24/1984SE |
| K842592 | Ames Tda Phenobarbital TestLET · Traditional | 08/17/1984SE |
| K842237 | Clinitek 200 Semi-Automated UrinalysisKQO · Traditional | 08/15/1984SE |
| K842238 | Clinitek 10 Semi-Auto Urinalysis SysKQO · Traditional | 07/25/1984SE |
| K842006 | Citoject Cartridge SyringeEJI · Traditional | 07/16/1984SE |
| K841816 | Optimate Igg TestDEW · Traditional | 06/22/1984SE |
| K841814 | Optimate Igm TestDFT · Traditional | 06/22/1984SE |
| K841815 | Optimate Iga TestCZN · Traditional | 06/01/1984SE |
| K841582 | Optimate Digoxin TestKXT · Traditional | 05/11/1984SE |
| K833977 | Seralyzer Drug Assay Control SerumDLJ · Traditional | 03/19/1984SE |
| K832825 | Seralyzer Theophylline Reagent StripsKLS · Traditional | 03/19/1984SE |
| K832088 | Ames Tda Netilmicin Test & SerumLCE · Traditional | 10/28/1983SE |
| K832791 | Serayzer Alt/Sgpt Reagent StripsCKC · Traditional | 10/14/1983SE |
| K832790 | Seralyzer Ast/Sgot Reagent StripsCIF · Traditional | 10/14/1983SE |
| K832684 | Seralyzer Triglycerides Reagent StripsCDT · Traditional | 10/04/1983SE |
| K832792 | Ames Tda Sisomicin Test-Control SerumDJB · Traditional | 09/29/1983SE |
| K832769 | Ames Tda Kanamycin Test-Control SerumKJI · Traditional | 09/29/1983SE |
| K832766 | Ames Tda Disopyramide TestKLT · Traditional | 09/29/1983SE |
| K832132 | Sera-Tek Mycoplasma Antibody TestGSB · Traditional | 09/20/1983SE |
| K831600 | Diastix Reagent Strips for UrinalysisJIL · Traditional | 09/08/1983SE |
| K832046 | Seralyzer Multicomponent CalibratorsJIX · Traditional | 08/11/1983SE |
| K831989 | Visidex II Reagent StripsCGA · Traditional | 08/08/1983SE |
| K831313 | Tissue-Tek V.I.P. 100/200IEO · Traditional | 07/28/1983SE |
| K831514 | Amwa Tda Theophylline TestLER · Traditional | 06/30/1983SE |
| K831400 | Ames Tda Procainamide TestLAR · Traditional | 06/02/1983SE |
| K831399 | Ames Tda N-Acetyl-Procainamide TestLAN · Traditional | 06/02/1983SE |
| K830758 | Azlin Azlocilin Sodium-Diag. ReagentJTT · Traditional | 05/25/1983SE |
| K830789 | Ames Tda Valproic Acid TestLEG · Traditional | 04/12/1983SE |
| K823801 | Ames Tda Ethosuximide TestDLF · Traditional | 01/14/1983SE |
| K821669 | Ames Tda Gentamicin TestDJB · Traditional | 12/15/1982SE |
| K823112 | Clinistat Tda SeriesKHO · Traditional | 11/29/1982SE |
| K822701 | Fluorostat FluorometerKHO · Traditional | 10/08/1982SE |
| K822046 | Seralyzer Hemoglobin CalibratorsKRZ · Traditional | 07/30/1982SE |
| K822045 | Seralyzer Hemoglobin Test ModuleKHG · Traditional | 07/30/1982SE |
| K822044 | Seralyzer Hemoglobin Reagent StripsKHG · Traditional | 07/30/1982SE |
| K821738 | Clini-Tek Semi-Automated Urinalysis SystKQO · Traditional | 07/06/1982SE |
| K821247 | Accudex Reagent StripsCGA · Traditional | 05/21/1982SE |
| K821179 | Visidex Reagent StripsCGA · Traditional | 05/14/1982SE |
| K820880 | Seralyzer CK Reagent StripsCGS · Traditional | 04/16/1982SE |
| K820075 | Seralyzer Creatinine Reagent StripsCGX · Traditional | 01/26/1982SE |
| K813580 | Q-Line LTCJJY · Traditional | 01/18/1982SE |
| K812753 | Ames Tda Quinidine TestLBZ · Traditional | 10/19/1981SE |
| K812558 | Tissue-Tek III Accu-Cut Rotary MicrotomeIDO · Traditional | 09/29/1981SE |
| K812518 | Ames Tda Theophylline TestLER · Traditional | 09/23/1981SE |
| K811342 | Reagent Strips for UrinalysisJRE · Traditional | 09/01/1981SE |
| K812100 | SeralyzerCHH · Traditional | 08/12/1981SE |
| K811952 | Ames Tda Carbamazepine TestKLT · Traditional | 07/15/1981SE |
| K811382 | Lab-Tek Jembec G.C. Culture SystemJTY · Traditional | 06/16/1981SE |
| K811392 | Ames Sera-Pak Glucose ReagentCGA · Traditional | 05/29/1981SE |
| K811026 | Ames Tda TM Amikacin TestKLQ · Traditional | 04/29/1981SE |
| K811025 | Ames Tda TM Phenytoin TestLES · Traditional | 04/29/1981SE |
| K811007 | Ames Tda TM Primidone TestLFT · Traditional | 04/29/1981SE |
| K810994 | Ames Tda TM Phenobarbital TestLET · Traditional | 04/29/1981SE |
| K810943 | Ames Tda Theophylline TestLER · Traditional | 04/17/1981SE |
| K810942 | Ames Tda Gentamicin TestLCQ · Traditional | 04/17/1981SE |
| K810941 | Ames Tda Tobramycin TestLCR · Traditional | 04/17/1981SE |
| K810639 | Seralyzer SystemCGA · Traditional | 03/31/1981SE |
| K803241 | Histological Embedding MediaKEO · Traditional | 01/28/1981SE |
| K803248 | Ames Sera-Pak Hemoglobin ReagentKHG · Traditional | 01/26/1981SE |
| K803237 | Ames Sera-Pak Albumin Reagent KitCIX · Traditional | 01/09/1981SE |
| K803107 | Ames Tda Amikacin Control SerumLAS · Traditional | 12/22/1980SE |
| K803019 | Seralyzer LDH Reagent Strips, CalibrCFJ · Traditional | 12/22/1980SE |
| K802742 | Sera-Pak Total Protein ReagentGGK · Traditional | 12/11/1980SE |
| K802743 | Ames Sera-Pak Cholesterol Reagent KitCHH · Traditional | 12/10/1980SE |
| K802724 | Ames Sera-Pak Uric Acid Reagent KitKNK · Traditional | 12/10/1980SE |
| K802654 | Ames Tda Primidone TestDJD · Traditional | 11/12/1980SE |
| K802255 | Ames Tda Phenobarbital TestLET · Traditional | 09/26/1980SE |
| K801956 | Tissue-Tek III Tissue Embedding Center · Traditional | 09/16/1980SE |
| K801928 | Lab-Tek Fta-Abs KitJWL · Traditional | 08/20/1980SE |
| K801736 | Ames Tda TM Phenytoin TestLES · Traditional | 08/20/1980SE |
| K801665 | Seralyzer Glucose Calibrators(Low&High)JIS · Traditional | 08/20/1980SE |
| K801664 | Seralyzer Glucose Test ModuleJQP · Traditional | 08/20/1980SE |
| K801663 | Seralyzer Glucose Reagent StripsCGA · Traditional | 08/20/1980SE |
| K801427 | Tissue-Tek III Mini-Rapid ProcessorIEO · Traditional | 07/28/1980SE |
| K801426 | Tissue-Tek III Microject Disp. Blade SysIDL · Traditional | 07/28/1980SE |
| K801270 | Test for Ketone in Urine(Acetoacetic AcJIN · Traditional | 07/08/1980SE |
| K801269 | Seralyzer Blood Urea Nitrogen(Bun)JGZ · Traditional | 07/08/1980SE |
| K801210 | Biostator Printer/PlotterJQP · Traditional | 06/17/1980SE |
| K801044 | Ames Glucometer Reflect. PhotometerJJQ · Traditional | 06/02/1980SE |
| K801130 | Ames Tda AmikacinKLQ · Traditional | 05/28/1980SE |
| K800899 | Lab-Tek Anacult Anaerobic Culture ChambeKZJ · Traditional | 05/23/1980SE |
| K800943 | Pentex Bovine Albumin 30% SolutionKSG · Traditional | 05/08/1980SE |
| K800848 | Seralyzer Uric Acid Reagent Strips -KNK · Traditional | 04/24/1980SE |
| K800724 | Ames Lab Management SystemJQP · Traditional | 04/16/1980SE |
| K800646 | Ames Tda Theophyl-Line TestKLS · Traditional | 04/10/1980SE |
| K800059 | Compur M-1000 Mini-PhotometerKHG · Traditional | 04/04/1980SE |
| K800524 | Seralyzer Reflectance Photometer/Calib.CIE · Traditional | 04/02/1980SE |
| K800170 | Ames Rialyze - Uptake Chrom. TubesKHQ · Traditional | 02/13/1980SE |
| K800169 | Ames Rialyze - Chromatography TubesCDX · Traditional | 02/13/1980SE |
| K800035 | Pentex Lipoprotein Cholesterol Solu.JJX · Traditional | 01/21/1980SE |
| K792292 | Ames Dextrometer Reflectance ColorimeterJJQ · Traditional | 12/06/1979SE |
| K792184 | Lab-Tek Ana Test KitDHN · Traditional | 11/30/1979SE |
| K791435 | Ames Tda/TobramycinKLB · Traditional | 08/16/1979SE |
| K790965 | Reagent Strips for UrinalysisCDM · Traditional | 06/28/1979SE |
| K790584 | Ames Tda/GentgmicinDJB · Traditional | 06/15/1979SE |
| K790581 | Chromatography TubesCDP · Traditional | 05/15/1979SE |
| K781961 | Control Strip for Visual UrinalysisJJW · Traditional | 02/08/1979SE |
| K781108 | Microcult-Gc Culture TestJSX · Traditional | 08/31/1978SE |
| K781181 | Cliniria Total T-4 (Ria) TestCDX · Traditional | 08/14/1978SE |
| K781180 | Cliniria T-3 Uptake TestKHQ · Traditional | 08/14/1978SE |
| K780393 | Biostator Glucose AnalyzerCGA · Traditional | 06/19/1978SE |
| K780163 | Redi-Disc Hemoglobin Gel Tube KitJBD · Traditional | 03/27/1978SE |
| K780075 | Rialyze DigoxinDPG · Traditional | 02/28/1978SE |
| K772099 | PrinterJJJ · Traditional | 01/26/1978SE |
| K772095 | Hemagglutination Inhibition TestDDR · Traditional | 01/05/1978SE |
| K771672 | Microcult-IdJXA · Traditional | 12/09/1977SE |
| K772088 | Ames T-3 Uptake Strip TestKHQ · Traditional | 12/06/1977SE |
| K772014 | Ames T-4 Strip TestCDX · Traditional | 11/02/1977SE |
| K771767 | Seralute TSH (Ria)JLW · Traditional | 10/25/1977SE |
| K771755 | 9-WAY Urine Test with AscorbicJIL · Traditional | 10/25/1977SE |
| K771713 | TEK-CHEK-2JJW · Traditional | 10/18/1977SE |
| K771004 | Amhs Blood Analy. Triglyceoides Reag. KiCDT · Traditional | 09/12/1977SE |
| K771559 | Hema-Tek II Slide StainerKPA · Traditional | 08/25/1977SE |
| K771308 | Tissue-Tek III V.I.P.IEO · Traditional | 08/22/1977SE |
| K771035 | Culture Test for Neisseria GonorrhoeaeJTY · Traditional | 07/05/1977SE |
| K770659 | Rialyze HPL (Ria)JMF · Traditional | 05/20/1977SE |
| K770390 | Urinalysis ProficiencyJJW · Traditional | 05/03/1977SE |
| K761310 | Mega-DiastixJIL · Traditional | 03/21/1977SE |
| K761306 | Clinilab Automated Urinalysis SystemKQO · Traditional | 03/21/1977SE |
| K761062 | Histo-Tek W/ Automatic CoverslipperIEO · Traditional | 03/07/1977SE |
| K761311 | Accraassay Rid KitsJZQ · Traditional | 12/30/1976SE |
| K761063 | Gammacord II Calculator InterfaceJQP · Traditional | 12/02/1976SE |
| K760572 | SeraluteCDX · Traditional | 11/23/1976SE |
| K760472 | Instrumented System for UrinalysisKQO · Traditional | 10/29/1976SE |
| K760481 | Filter, Particulate ArrestingFRF · Traditional | 09/15/1976SE |
| K760278 | Slide, Lab-Tek Covered MicroKEW · Traditional | 08/30/1976SE |
PMA approvals
- P800032 Biostator Glucose Controller · 05/28/1981 · 1 supplement