K770273 is an FDA 510(k) clearance for the TEST, AMMONIA, BMC REAGENTSET. This device is classified as a Enzymatic Method, Ammonia (Class I - General Controls, product code JIF).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on March 1, 1977, 15 days after receiving the submission on February 14, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1065.
| 510(k) Number | K770273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1977 |
| Decision Date | March 01, 1977 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIF — Enzymatic Method, Ammonia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1065 |