Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chiron Diagnostics Corp. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
152 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | 1999-08-05 | 41 | 0 |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | 1999-06-30 | 54 | 0 |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | 1999-06-18 | 31 | 0 |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-10-15 | 76 | 3 |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-08-12 | 78 | 0 |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | 1998-08-12 | 110 | 0 |
| K981592 | ACS:CENTAUR AFP | Chiron Diagnostics Corp. | 1998-07-07 | 64 | 0 |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | Chiron Diagnostics Corp. | 1998-03-03 | 20 | 0 |
| K974029 | ACS TOBRAMYCIN | Chiron Diagnostics Corp. | 1998-02-12 | 112 | 0 |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Chiron Diagnostics Corp. | 1997-12-08 | 20 | 0 |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANT | Chiron Diagnostics Corp. | 1997-08-08 | 164 | 0 |
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) | Chiron Diagnostics Corp. | 1997-07-17 | 92 | 4 |
| K970546 | ACS DIGITOXIN | Chiron Diagnostics Corp. | 1997-07-14 | 152 | 1 |
| K971405 | SPECIALITY URINE 1,2 | Chiron Diagnostics Corp. | 1997-06-16 | 61 | 0 |
| K970386 | ACS ESTADIOL-6 II | Chiron Diagnostics Corp. | 1997-06-04 | 121 | 0 |
| K971071 | LIQUID LIGAND 1,2,3 | Chiron Diagnostics Corp. | 1997-04-23 | 30 | 0 |
| K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND | Chiron Diagnostics Corp. | 1997-04-08 | 22 | 0 |
| K970979 | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 | Chiron Diagnostics Corp. | 1997-04-02 | 16 | 0 |
| K970539 | CHIRON DIAGNOSTICS ACS:180TU P | Chiron Diagnostics Corp. | 1997-03-24 | 40 | 0 |
| K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | Chiron Diagnostics Corp. | 1997-02-14 | 79 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda