510(k) K030873 ยท JIF Enzymatic Method, Ammonia
RANDOX AMMONIA
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, May 12, 2003 |
| Received | Mar 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2020 | RANDOX LABORATORIES, LTD. AM1015 Randox Ammonia (NH3), Enzymatic UV Method
For the quantitative in vitro determination of Ammonia in plasma Terminated |
JIF | None listed |
| Jul 30, 2020 | RANDOX LABORATORIES, LTD. AM1054 Randox Ammonia (NH3), Enzymatic UV Method
For the quantitative in vitro determination of Ammonia in plasma Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.