510(k) K973589 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
LIQUID LDH-L REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Oct 8, 1997 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2017 | Medtest Holdings, Inc. Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set
Model Number(s): L7572.
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Terminated |
CFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.