Company ยท US
Chiron Diagnostics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 1999. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 |
| MOI | System, Test, Immunological, Antigen, Tumor | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| LCR | Fluorescent Immunoassay, Tobramycin | 1 |
| LFM | Enzyme Immunoassay, Digitoxin | 1 |
| LOQ | Device, General Purpose, Hematology | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 1999 | K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY Chiron Diagnostics Corp. | DBF |
| Jun 30, 1999 | K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE Chiron Diagnostics Corp. | CGN |
| Jun 18, 1999 | K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 Chiron Diagnostics Corp. | CDP |
| Oct 15, 1998 | K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY Chiron Diagnostics Corp. | MOI |
| Aug 12, 1998 | K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY Chiron Diagnostics Corp. | LTJ |
| Aug 12, 1998 | K981478 | ACS:CENTAUR CEA Chiron Diagnostics Corp. | DHX |
| Jul 7, 1998 | K981592 | ACS:CENTAUR AFP Chiron Diagnostics Corp. | LOQ |
| Mar 3, 1998 | K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) Chiron Diagnostics Corp. | MMI |
| Feb 12, 1998 | K974029 | ACS TOBRAMYCIN Chiron Diagnostics Corp. | LCR |
| Dec 8, 1997 | K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN Chiron Diagnostics Corp. | DDR |
| Aug 8, 1997 | K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) Chiron Diagnostics Corp. | MOI |
| Jul 17, 1997 | K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER Chiron Diagnostics Corp. | MOI |
| Jul 14, 1997 | K970546 | ACS DIGITOXIN Chiron Diagnostics Corp. | LFM |
| Jun 16, 1997 | K971405 | SPECIALITY URINE 1,2 Chiron Diagnostics Corp. | JJY |
| Jun 4, 1997 | K970386 | ACS ESTADIOL-6 II Chiron Diagnostics Corp. | CHP |
| Apr 23, 1997 | K971071 | LIQUID LIGAND 1,2,3 Chiron Diagnostics Corp. | JJY |
| Apr 8, 1997 | K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 Chiron Diagnostics Corp. | JJY |
| Apr 2, 1997 | K970979 | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 Chiron Diagnostics Corp. | JJY |
| Mar 24, 1997 | K970539 | CHIRON DIAGNOSTICS ACS:180TU P Chiron Diagnostics Corp. | KHQ |
| Feb 14, 1997 | K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY Chiron Diagnostics Corp. | KLT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||