K812095 is an FDA 510(k) clearance for the ENXYMATIC CREATININE TEST. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on August 31, 1981, 38 days after receiving the submission on July 24, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K812095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1981 |
| Decision Date | August 31, 1981 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |