Crestat Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Crestat Diagnostics, Inc.” (first 1990, latest 1998), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 195 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 | 3 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 | 1 |
Plus 12 more product codes.
Review panels
- Immunology (17)
- Clinical Chemistry (8)
- Hematology (3)
- Clinical Toxicology (1)
Most recent Crestat Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | CFR | 1998-09-03 | 178 |
| K981276 | N-ASSAY L D-BIL | CIG | 1998-05-01 | 23 |
| K981289 | N-ASSAY L T-BIL | CIG | 1998-04-27 | 19 |
| K980902 | N-ASSAY L AST/GOT | CIT | 1998-03-26 | 16 |
| K980900 | N-ASSAY CPK-L | CGS | 1998-03-26 | 16 |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | DDQ | 1997-10-20 | 125 |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | GGP | 1997-10-20 | 144 |
| K964296 | N-ASSAY TIA APO B TEST KIT | DER | 1997-08-01 | 276 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | DER | 1997-08-01 | 276 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | DER | 1997-08-01 | 276 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Crestat Diagnostics, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Crestat Diagnostics, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Crestat Diagnostics, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Crestat Diagnostics, Inc.” (first 1990, latest 1998), across 22 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 Crestat Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Crestat Diagnostics, Inc. is 195 days.
Which FDA product codes appear under Crestat Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CFN (Method, Nephelometric, Immunoglobulins (G, A, M), 3); DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control, 3); CIG (Diazo Colorimetry, Bilirubin, 2).
Next steps
- See all 29 Crestat Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFN, Crestat Diagnostics, 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.