Chimera Research & Chemical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Chimera Research & Chemical, Inc.” (first 1994, latest 1997), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 132 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| KQO | Automated Urinalysis System | 2 | 2 |
| DMP | Digoxin Control Serum, Ria | 1 | 1 |
| DPM | Columns, Liquid Chromatography | 1 | 1 |
| IFT | Glutaraldehyde | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Clinical Toxicology (2)
- Pathology (1)
Most recent Chimera Research & Chemical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970087 | CR PERFECT | CGX | 1997-03-06 | 55 |
| K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE | KQO | 1996-05-14 | 403 |
| K953393 | TOX PERFECT A TUBE | DMP | 1995-10-06 | 84 |
| K952501 | TOX PERFECT B TUBES AND REAGENTS | DPM | 1995-08-24 | 86 |
| K950142 | CR PERFECT | CGX | 1995-05-25 | 132 |
| K940768 | AD PERFECT | IFT | 1995-02-17 | 364 |
| K935408 | UA PERFECT | KQO | 1994-06-13 | 216 |
Recalls
openFDA lists no recalls under a recalling firm named Chimera Research & Chemical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chimera Research & Chemical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Chimera Research & Chemical, Inc.” (first 1994, latest 1997), across 5 product codes in 3 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 Chimera Research & Chemical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chimera Research & Chemical, Inc. is 132 days.
Which FDA product codes appear under Chimera Research & Chemical, Inc.?
The most frequent FDA product codes under this applicant name are CGX (Alkaline Picrate, Colorimetry, Creatinine, 2); KQO (Automated Urinalysis System, 2); DMP (Digoxin Control Serum, Ria, 1).
Next steps
- See all 7 Chimera Research & Chemical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGX, Chimera Research & Chemical, Inc.'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.