510(k) K984402 ยท JIF Enzymatic Method, Ammonia
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Dec 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2012 | Beckman Coulter Inc. SYNCHRON Ammonia (AMM) Reagent
Product Usage:
AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.