K854766 is an FDA 510(k) clearance for the CREATININE PAP. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 17, 1986, 51 days after receiving the submission on November 27, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K854766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1985 |
| Decision Date | January 17, 1986 |
| Days to Decision | 51 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 |