Diagnostic Reagents, Inc.
Medical device manufacturer in Sunnyvale, CA.
66510(k) clearances
0PMA approvals
0recalls
Device types
- DLJ Calibrators, Drug Specific 7
- DKB Calibrators, Drug Mixture 6
- DJR Enzyme Immunoassay, Methadone 3
- LCM Enzyme Immunoassay, Phencyclidine 3
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 3
- DIS Enzyme Immunoassay, Barbiturate 3
- JIS Calibrator, Primary 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- LFH U.V. Spectrometry, Tricyclic Antidepressant… 2
- JXM Enzyme Immunoassay, Benzodiazepine 2
- KXT Enzyme Immunoassay, Digoxin 2
- DKZ Enzyme Immunoassay, Amphetamine 2
- LDJ Enzyme Immunoassay, Cannabinoids 2
- KHQ Radioassay, Triiodothyronine Uptake 2
- LAS Drug Specific Control Materials 1
- DIF Drug Mixture Control Materials 1
- DMT Enzymatic Method, Alcohol Dehydrogenase… 1
- JJX Single (Specified) Analyte Controls… 1
- LAN Enzyme Immunoassay, N-Acetylprocainamide 1
- JJA Radio-Labeled Iron Method, Iron (Non-Heme) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
| K962463 | Procainamide Enzyme ImmunoassayLAR · Traditional | 08/14/1996SE |
| K961988 | Valproic Acid Eia TestLEG · Traditional | 07/16/1996SE |
| K961373 | Acetaminophen Serum Tox Eia AssayLDP · Traditional | 07/08/1996SE |
| K961393 | Tricyclics Serum Tox AssayLFH · Traditional | 06/12/1996SE |
| K960708 | Benzodiazepine Serum Tox Eia TestJXM · Traditional | 05/20/1996SE |
| K961273 | AED CalibratorsDKB · Traditional | 05/15/1996SE |
| K960664 | Barbiturate Serum Tox Eia AssayDIS · Traditional | 05/06/1996SE |
| K961372 | Serum Tox CalibratorDKB · Traditional | 05/01/1996SE |
| K961131 | Salicylate AssayDKJ · Traditional | 04/29/1996SE |
| K960187 | Cocaine Metabolite Eia TestDIO · Traditional | 04/02/1996SE |
| K960526 | Primidone Eia TestDJP · Traditional | 03/18/1996SE |
| K955928 | Barbiturate Eia Essay (Modification)DIS · Traditional | 03/11/1996SE |
| K955100 | Carbamazepine Eia TestKLT · Traditional | 12/13/1995SE |
| K952178 | Ph-Detect TestJQY · Traditional | 10/20/1995SE |
| K952596 | Theophylline Enzyme ImmunoassayKLS · Traditional | 08/11/1995SE |
| K951585 | T-Uptake CalibratorsJIS · Traditional | 06/15/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | 05/15/1995SE |
| K946210 | Phenobarbital Enzyme ImmunoassayDLZ · Traditional | 02/10/1995SE |
| K945725 | Phenytion Eia TestDIP · Traditional | 02/03/1995SE |
| K945338 | Theophylline CalibratorsDLJ · Traditional | 01/17/1995SE |
| K945316 | Phenobarbital CalibratorsDLJ · Traditional | 01/04/1995SE |
| K944703 | Thyroxine Enzyme ImmunoassayKLI · Traditional | 12/09/1994SE |
| K945337 | Phenytoin CalibratorsDLJ · Traditional | 12/07/1994SE |
| K944701 | CalibratorsJIS · Traditional | 11/21/1994SE |
| K943998 | Cannabinoid Eia AssayLDJ · Traditional | 11/04/1994SE |
| K943414 | Propoxphene Eia TestJXN · Traditional | 09/09/1994SE |
| K940935 | Urine CalibratorDKB · Traditional | 07/06/1994SE |
| K940123 | Methaqualone Enzyme ImmunoassayKXS · Traditional | 05/03/1994SE |
| K935101 | Urine Calibrators and Controls ModificationDKB · Traditional | 01/27/1994SE |
| K934667 | Methadone Enzyme ImmunoassayDJR · Traditional | 01/26/1994SE |
| K934891 | Amphetamines Eia Assay ModificationDKZ · Traditional | 01/13/1994SE |
| K935320 | Phencyclidine Eia AssayLCM · Traditional | 12/29/1993SE |
| K935016 | Cocaine Metabolite Eia Assay ModificationDIO · Traditional | 12/03/1993SE |
| K931780 | Methadone Metabolite Eia AssayDJR · Traditional | 08/23/1993SE |
| K930529 | Benzodiazepine Enzyme ImmunoassayJXM · Traditional | 08/05/1993SE |
| K931506 | Urine Calibrator and ControlDLJ · Traditional | 07/28/1993SE |
| K932113 | Cannabinoid Urine ControlsJJX · Traditional | 06/29/1993SE |
| K923783 | Ethyl Alcohol AssayDMT · Traditional | 01/21/1993SE |
| K925491 | Barbiturate Eia TestDIS · Traditional | 12/30/1992SE |
| K924733 | Ethyl Alcohol Calibrators & ControlDNN · Traditional | 12/09/1992SE |
| K923386 | THC Urine CalibratorsDLJ · Traditional | 09/14/1992SE |
| K921554 | Amphetamines Eia TestDKZ · Traditional | 05/04/1992SE |
| K921141 | Cannabinoid Urine ControlsLAS · Traditional | 04/17/1992SE |
| K920957 | Phencyclidine Eia Assay, ModificationLCM · Traditional | 03/18/1992SE |
| K920749 | THC Urine CalibratorsDLJ · Traditional | 03/18/1992SE |
| K920477 | Drug of Abuse Urine ControlDIF · Traditional | 03/18/1992SE |
| K920208 | Urine a CalibratorDKB · Traditional | 03/04/1992SE |
| K920311 | Cannabinoid Eia TestLDJ · Traditional | 02/27/1992SE |
| K915180 | Opiate Eia AssayDJG · Traditional | 01/22/1992SE |
| K915371 | Cocaine Metabolite Eia TestDIO · Traditional | 12/18/1991SE |
| K915179 | Phencyclidine Eia AssayLCM · Traditional | 12/09/1991SE |
| K821725 | T3 Diagnostic Kit RiaCDP · Traditional | 06/24/1982SE |
| K821722 | T3 Uptake Diagnostic KitKHQ · Traditional | 06/24/1982SE |
| K820253 | Simul-Fer Serum Iron Test KitJJA · Traditional | 05/12/1982SE |
| K820252 | TBG Diagnostic KitCEE · Traditional | 05/05/1982SE |
| K820251 | T4 Diagnostic KitCDP · Traditional | 05/05/1982SE |