Cholestech Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Cholestech Corp.” (first 1990, latest 2004), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 10 | 10 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CIS | Hydrazone Colorimetry, Ast/Sgot | 1 | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
Review panels
- Clinical Chemistry (19)
- Immunology (1)
Most recent Cholestech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | DCK | 2004-06-18 | 106 |
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | CIS | 2003-09-05 | 66 |
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | CKD | 1999-09-09 | 104 |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | CDN | 1997-07-24 | 55 |
| K954778 | CHOLESTECH LDX SYSTEM | LBS | 1995-11-24 | 66 |
| K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL | CHH | 1995-02-22 | 99 |
| K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL | CHH | 1995-02-22 | 99 |
| K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL | CHH | 1995-02-22 | 99 |
| K946064 | TOTAL CHOLESTEROL CASSETTE | CHH | 1995-02-22 | 99 |
| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | CHH | 1995-02-22 | 99 |
10 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-08-09.
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 Cholestech Corp.?
FDA lists 20 510(k) clearances under the applicant name “Cholestech Corp.” (first 1990, latest 2004), across 9 product codes in 2 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 Cholestech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cholestech Corp. is 82 days.
Which FDA product codes appear under Cholestech Corp.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 10); CGA (Glucose Oxidase, Glucose, 2); LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, 2).
Next steps
- See all 20 Cholestech Corp. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Cholestech 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.