510(k) K970684 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
LACTATE DEHYDROGENASE (LD)
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, May 7, 1997 |
| Received | Feb 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2020 | Randox Laboratories Ltd. Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. T Terminated |
CFJ | None listed |
| Aug 11, 2020 | Randox Laboratories Ltd. Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This pro Terminated |
CFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.