Chiron Diagnostics Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Chiron Diagnostics Corp.” (first 1997, latest 1999), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 62 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| MOI | System, Test, Immunological, Antigen, Tumor | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (9)
- Immunology (7)
- Clinical Toxicology (3)
- Hematology (1)
Most recent Chiron Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | DBF | 1999-08-05 | 41 |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | CGN | 1999-06-30 | 54 |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | CDP | 1999-06-18 | 31 |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | MOI | 1998-10-15 | 76 |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | LTJ | 1998-08-12 | 78 |
| K981478 | ACS:CENTAUR CEA | DHX | 1998-08-12 | 110 |
| K981592 | ACS:CENTAUR AFP | LOQ | 1998-07-07 | 64 |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | MMI | 1998-03-03 | 20 |
| K974029 | ACS TOBRAMYCIN | LCR | 1998-02-12 | 112 |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | DDR | 1997-12-08 | 20 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chiron Diagnostics Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Chiron Vision Corp. (34 510(k)s)
- Chiron Ophthalmics (10 510(k)s)
- Chiron Intraoptics (4 510(k)s)
- Chiron Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chiron Diagnostics Corp.?
FDA lists 20 510(k) clearances under the applicant name “Chiron Diagnostics Corp.” (first 1997, latest 1999), across 15 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chiron Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chiron Diagnostics Corp. is 62 days.
Which FDA product codes appear under Chiron Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); MOI (System, Test, Immunological, Antigen, Tumor, 3); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 20 Chiron Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Chiron Diagnostics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.