K971345 is an FDA 510(k) clearance for the CHOL OR CHOLESTEROL. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 29, 1997, 49 days after receiving the submission on April 10, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K971345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1997 |
| Decision Date | May 29, 1997 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |