K914160 is an FDA 510(k) clearance for the CHOLESTEROL REGEANT SET. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on January 30, 1992, 135 days after receiving the submission on September 17, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K914160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1991 |
| Decision Date | January 30, 1992 |
| Days to Decision | 135 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 |