K880651 is an FDA 510(k) clearance for the PARAMAX AMMONIA REAGENT. This device is classified as a Enzymatic Method, Ammonia (Class I - General Controls, product code JIF).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 24, 1988, 36 days after receiving the submission on February 17, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1065.
| 510(k) Number | K880651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1988 |
| Decision Date | March 24, 1988 |
| Days to Decision | 36 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 |