Chiron Diagnostics Corp.
Medical device manufacturer in Medfield, MA.
20510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 4
- MOI System, Test, Immunological, Antigen, Tumor 3
- KLT Enzyme Immunoassay, Carbamazepine 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- CHP Radioimmunoassay, Estradiol 1
- LFM Enzyme Immunoassay, Digitoxin 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- LCR Fluorescent Immunoassay, Tobramycin 1
- MMI Immunoassay Method, Troponin Subunit 1
- LOQ Device, General Purpose, Hematology 1
- DHX System, Test, Carcinoembryonic Antigen 1
- LTJ Prostate-Specific Antigen (Psa) For… 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- CGN Acid, Folic, Radioimmunoassay 1
- DBF Ferritin, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K992157 | Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional | 08/05/1999SE |
| K991582 | Chiron Diagnostics Acs: 180 FolateCGN · Traditional | 06/30/1999SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | 06/18/1999SE |
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional | 10/15/1998SE |
| K981839 | Acs:Centaur PSA2 ImmunoassayLTJ · Traditional | 08/12/1998SE |
| K981478 | Acs:Centaur CeaDHX · Traditional | 08/12/1998SE |
| K981592 | Acs:Centaur AfpLOQ · Traditional | 07/07/1998SE |
| K980528 | Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional | 03/03/1998SE |
| K974029 | Acs TobramycinLCR · Traditional | 02/12/1998SE |
| K974325 | Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional | 12/08/1997SE |
| K970695 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | 08/08/1997SE |
| K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerMOI · Traditional | 07/17/1997SE |
| K970546 | Acs DigitoxinLFM · Traditional | 07/14/1997SE |
| K971405 | Speciality Urine 1,2JJY · Traditional | 06/16/1997SE |
| K970386 | Acs ESTADIOL-6 IICHP · Traditional | 06/04/1997SE |
| K971071 | Liquid Ligand 1,2,3JJY · Traditional | 04/23/1997SE |
| K970956 | Certain Complete Levels 1,2, and 3; CVM Levels 1,2,3,4, and 5JJY · Traditional | 04/08/1997SE |
| K970979 | Liquid CSF(LCR)1, Liquid CSF(LCR)2JJY · Traditional | 04/02/1997SE |
| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | 03/24/1997SE |
| K964765 | Chiron Diagnostics Acs: 180 Carbamazepine AssayKLT · Traditional | 02/14/1997SE |