K981920 is an FDA 510(k) clearance for the AMM. This device is classified as a Enzymatic Method, Ammonia (Class I - General Controls, product code JIF).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 22, 1998, 51 days after receiving the submission on June 1, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1065.
| 510(k) Number | K981920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1998 |
| Decision Date | July 22, 1998 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIF — Enzymatic Method, Ammonia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1065 |