Ciba Corning Diagnostics Corp.
Medical device manufacturer in Irvine, CA.
125510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 13
- JJE Analyzer, Chemistry (Photometric… 7
- DHB System, Test, Radioallergosorbent (Rast)… 7
- CHL Electrode Measurement, Blood-Gases (Pco2… 7
- CDD Radioassay, Vitamin B12 4
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 4
- JGS Electrode, Ion Specific, Sodium 4
- CEP Radioimmunoassay, Luteinizing Hormone 3
- JHI Visual, Pregnancy Hcg, Prescription Use 3
- CDX Radioimmunoassay, Total Thyroxine 3
- KHQ Radioassay, Triiodothyronine Uptake 3
- LJC Enzyme Linked Immunoabsorbent Assay… 3
- DIF Drug Mixture Control Materials 2
- JHX Fluorometric Method, Cpk Or Isoenzymes 2
- JJS Controls For Blood-Gases, (Assayed And… 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 2
- JJX Single (Specified) Analyte Controls… 2
- DBF Ferritin, Antigen, Antiserum, Control 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | 12/13/1995SE |
| K953021 | Acs PhenobarbitalDIS · Traditional | 12/11/1995SE |
| K953020 | Acs GentamicinLCD · Traditional | 08/02/1995SE |
| K951169 | Ciba Corining Acs Theophylline ImmunoassayLGS · Traditional | 06/20/1995SE |
| K951059 | Ciba Corning Acs Vancomycin ImmunoassayLEH · Traditional | 06/19/1995SE |
| K951796 | Ciba Corning Acs Thyroid Stimulating Hormone (TSH-3) ImmunoassayJLW · Traditional | 06/13/1995SE |
| K945367 | Ciba Corning Acs Cortisol ImmunoassayCGR · Traditional | 05/05/1995SE |
| K946224 | Certain(R) Elite Level 1, 2 and 3JJS · Traditional | 01/30/1995SE |
| K946206 | Ciba Corning 8-- Series Co-OximeterCHL · Traditional | 01/30/1995SE |
| K943297 | Ciba Corning Acs Folate AssayCGN · Traditional | 12/12/1994SE |
| K935228 | Model 644 Sweat DiluentCGZ · Traditional | 08/01/1994SE |
| K940810 | Ciba Corning ACS:180 Auto Chemilumin Syst, ModifJJE · Traditional | 05/23/1994SE |
| K934317 | Cidba Corning Acs Cortisol ImmunoassayJFT · Traditional | 05/13/1994SE |
| K940482 | Ciba Corning Acs FT3 ImmunoassayCEC · Traditional | 04/26/1994SE |
| K934594 | Magic Lite SQ Specific Ige Immunoassay SystemDGC · Traditional | 04/21/1994SE |
| K930534 | TMC I, IIJJY · Traditional | 04/04/1994SE |
| K935219 | Fertility Plus 1, 2, 3JJY · Traditional | 03/22/1994SE |
| K935830 | Ciba Corning 248 Ph/Blood Gas AnalyzerCHL · Traditional | 02/03/1994SE |
| K934907 | 860 Measurment SystemCHL · Traditional | 01/03/1994SE |
| K934562 | Ciba Corning Acs Testosterone ImmunoassayCDZ · Traditional | 12/10/1993SE |
| K932747 | Ciba Corning Acs Free T3 ImmunoassayCDP · Traditional | 12/03/1993SE |
| K932715 | Ciba Corning Acs Estradiol ImmunoassayCHP · Traditional | 12/03/1993SE |
| K933373 | Ciba Corning 300 Series SystemJGS · Traditional | 08/19/1993SE |
| K932955 | Ciba Corning Acs Progesterone ImmunoassayJLS · Traditional | 08/02/1993SE |
| K931213 | Acs Digoxin ImmunoassayKXT · Traditional | 06/07/1993SE |
| K925277 | Ciba Corning Acs HCG ImmunoassayJHI · Traditional | 03/19/1993SE |
| K923420 | Ciba Corning Magic Lite SQ Specific Ige AssayDHB · Traditional | 02/23/1993SE |
| K925257 | Ciba Corning Acs T Uptake ImmunoassayKHQ · Traditional | 12/28/1992SE |
| K923633 | Multiqual Assay ProductsJJY · Traditional | 10/13/1992SE |
| K923632 | Multiqual Unassayed ProductsJJY · Traditional | 10/13/1992SE |
| K914959 | Magic Lite SQ Specific Ige Immunoassay SystemDHB · Traditional | 08/20/1992SE |
| K921403 | Model 654 AnalyzerJIH · Traditional | 07/30/1992SE |
| K921678 | Ciba Corning Acs Folate ImmunoassayJIX · Traditional | 06/09/1992SE |
| K920372 | Acs Total Ige ImmunoassayDGC · Traditional | 04/08/1992SE |
| K915366 | Model 560 Express Clinical Chemistry AnalyzerJJE · Traditional | 03/17/1992SE |
| K915332 | Model 795 Fluorometer/DensitometerJQT · Traditional | 02/18/1992SE |
| K914619 | CVMJJY · Traditional | 11/22/1991SE |
| K913646 | Ciba Corning Acs T3 ImmunoassayCDD · Traditional | 10/25/1991SE |
| K913332 | Ciba Corning Model 270 Co-OximeterDQA · Traditional | 10/23/1991SE |
| K912583 | Magic Lite TSH (HS) ImmunoassayJLW · Traditional | 08/12/1991SE |
| K912582 | Magic Lite SQ Specific Ige Immunoassay SystemDHB · Traditional | 07/31/1991SE |
| K911984 | Anemia I, IIJJY · Traditional | 06/13/1991SE |
| K910684 | Ciba Corning Acs FT4 ImmunoassayCEC · Traditional | 05/01/1991SE |
| K910981 | Ciba Corning Acs TSH ImmunoassayJLW · Traditional | 04/30/1991SE |
| K911093 | Ciba Corning Acs T Uptake ImmunoassayKHQ · Traditional | 04/29/1991SE |
| K911121 | Ciba Corning Acs CKMB ImmunoassayJHX · Traditional | 04/03/1991SE |
| K904189 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | 03/27/1991SE |
| K905054 | Ciba Corning Model 980 Magic Lite Allergy ManagerDHB · Traditional | 03/22/1991SE |
| K905770 | Ciba Corning Acs Ferritin ImmunoassayDBF · Traditional | 03/12/1991SE |
| K910343 | Ciba Corning Acs Vitamin B12 ImmunoassayCDD · Traditional | 03/06/1991SE |
| K910198 | Ciba Corning Acs LH ImmunoassayCEP · Traditional | 02/04/1991SE |
| K905532 | Ciba Corning Acs T4 ImmunoassayCDX · Traditional | 01/15/1991SE |
| K903637 | Alrgn SetDHB · Traditional | 11/21/1990SE |
| K904649 | Ciba Corning Acs FSH ImmunoassayCGJ · Traditional | 11/20/1990SE |
| K904714 | Ciba Corning Acs Prolactin ImmunoassayCFT · Traditional | 11/07/1990SE |
| K904123 | Ciba Corning Acs HCG ImmunoassayJHI · Traditional | 10/03/1990SE |
| K904188 | Ciba Corning Model 238 Ph/ Blood Gas AnalyzerCHL · Traditional | 09/27/1990SE |
| K902861 | Ciba Corning Acs Digoxin ImmunoassayDON · Traditional | 09/10/1990SE |
| K902270 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | 07/31/1990SE |
| K902235 | LVM Quality Control SerumJJY · Traditional | 07/17/1990SE |
| K902398 | Ciba Corning Magic Lite LH ImmunoassayCEP · Traditional | 06/28/1990SE |
| K902336 | Ciba Corning ACS:180 Automated ChemiluminescenceJJE · Traditional | 06/18/1990SE |
| K901212 | Lig/Tdm a, B, CJJY · Traditional | 05/01/1990SE |
| K896592 | Ciba Corning Magic Lite SQ Specific Ige AssayDHB · Traditional | 12/04/1989SE |
| K895122 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | 10/30/1989SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | 10/30/1989SE |
| K894988 | Ciba Corning Magic Lite Prolactin ImmunoassayCFT · Traditional | 10/12/1989SE |
| K893682 | Kit- Ciba Corning L-Tdm I, II, IIIDIF · Traditional | 09/28/1989SE |
| K893838 | Modified Model 570 Clinical Chemistry AnalyzerJQP · Traditional | 08/31/1989SE |
| K893684 | Ciba Corning Magic Lite Folate ImmunoassayCGN · Traditional | 07/27/1989SE |
| K893835 | Dau I, Dau II, Dau III and Dau IV Control UrineDIF · Traditional | 07/25/1989SE |
| K892500 | Ciba Corning Model 570 Alliance I.S.E. ModuleJGS · Traditional | 07/20/1989SE |
| K885024 | Alkaline Phosphatase Isoenzyme SystemCIN · Traditional | 02/17/1989SE |
| K884769 | Model 654 a Sodium, Potassium & Lithium Ise AnalyCEM · Traditional | 01/17/1989SE |
| K884687 | Ciba Corning Magic Lite FSH ImmunoassayCGJ · Traditional | 12/06/1988SE |
| K883813 | Ciba Corning Blood Collection Capillary TubeJKA · Traditional | 11/10/1988SE |
| K883722 | Ciba Corning Magic Lite Vitamin B12 ImmunoassayCDD · Traditional | 11/04/1988SE |
| K884185 | Ciba Corning Magic Lite Total Ige ImmunoassayDHB · Traditional | 10/27/1988SE |
| K883927 | Ciba Corning Magic Lite HCG ImmunoassayJHI · Traditional | 10/13/1988SE |
| K882560 | Ciba Corning Magic Lite Intact PTH ImmunoassayCEW · Traditional | 10/13/1988SE |
| K881679 | Ciba Corning Magic Lite Digoxin ImmunoassayDON · Traditional | 07/08/1988SE |
| K880353 | Ciba Corning Model 280 Ph/Blood Gas SystemGKR · Traditional | 06/15/1988SE |
| K875098 | Ciba Corning Model 644JXR · Traditional | 03/03/1988SE |
| K875117 | Ciba Corning Balanced Heparin for Ca++CBT · Traditional | 02/29/1988SE |
| K874584 | Triglyerides Test KitCDT · Traditional | 01/21/1988SE |
| K874603 | Ciba Corning T4 Lipia (Liposome Immunoassay)KLI · Traditional | 12/18/1987SE |
| K873945 | Ciba Corning Magic Lite T3 ImmunoassayCDP · Traditional | 11/23/1987SE |
| K873749 | Ciba Corning/Shimadzu Model 570 Chem. AnalyzerJJE · Traditional | 10/19/1987SE |
| K873573 | Ciba Corning Magic Lite FerritinDBF · Traditional | 10/07/1987SE |
| K873450 | Tri-Level Ligand ControlJJX · Traditional | 09/21/1987SE |
| K872302 | Model 550 Express Clinical Chemistry AnalyzerJJE · Traditional | 09/08/1987SE |
| K872888 | Ciba Corning 288 Ph/Blood Gas SystemJQY · Traditional | 08/25/1987SE |
| K872023 | Amylase Test KitJFJ · Traditional | 08/05/1987SE |
| K872716 | Ciba Corning Model 580 Alliance I.S.E. ModuleJGS · Traditional | 07/31/1987SE |
| K872286 | Ciba Corning Magic Lite FT4 ImmunoassayCDX · Traditional | 07/21/1987SE |
| K871028 | Ciba Corning Model 664/FAST 4 SystemJGS · Traditional | 05/28/1987SE |
| K871874 | Ciba Corning Magic Lite Analyzer IIJJQ · Traditional | 05/26/1987SE |
| K870987 | Ciba Corning Magic(R) Lite CKMB ImmunoassayJHX · Traditional | 05/26/1987SE |
| K864877 | Tri-Level Ligand ControlDHX · Traditional | 05/21/1987SE |
| K870965 | Ciba Corning Magic(R) Lite T4 ImmunoassayCDX · Traditional | 05/14/1987SE |
| K870833 | Ciba Corning/Shimadzu Model 580 Clini. Chem. AnalyJJE · Traditional | 04/01/1987SE |
| K865036 | Ciba Corning Model 278 Ph/Blood Gas SystemCHL · Traditional | 03/06/1987SE |
| K864557 | 710 PlusJQP · Traditional | 02/25/1987SE |
| K870036 | Bayer Healthcare Rapidqc PlusJJS · Traditional | 01/14/1987SE |
| K864132 | Ciba Corning Magic(R) Lite Tu ImmunoassayKHQ · Traditional | 12/16/1986SE |
| K862233 | Ciba Corning Prisma T4 Lipia (Liposome)KLI · Traditional | 10/14/1986SE |
| K863745 | Abnormal Spinal Fluid ControlJJY · Traditional | 10/07/1986SE |
| K862235 | Ciba Corning Magic Lite AnalyzerJJE · Traditional | 09/08/1986SE |
| K862407 | Ciba Corning Magic Lite TSH ImmunoassayJLW · Traditional | 08/29/1986SE |
| K860999 | Gilford Uniqual Abnormal Control Serum/AssayedJJY · Traditional | 07/02/1986SE |
| K861998 | Total Bilirubin Test KitCIG · Traditional | 06/27/1986SE |
| K861068 | Gilford Uniqual Normal Control Serum - AssayedJJY · Traditional | 04/07/1986SE |
| K861000 | Gilford Uniqual Normal Control Serum/UnassayedJJY · Traditional | 04/03/1986SE |
| K860998 | Gilford Uniqual Abnormal Control Serum/UnassayedJJY · Traditional | 04/03/1986SE |
| K854945 | Magic No Boil B12/FOLATE RadioimmunoassayCDD · Traditional | 02/11/1986SE |