510(k) K974620 ยท JIF Enzymatic Method, Ammonia
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
| Applicant | Trace America, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Dec 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2007 | Thermo Fisher Scientific Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.