510(k) K870143 ยท JIF Enzymatic Method, Ammonia
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 11, 1987 |
| Received | Jan 13, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870143
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.