510(k) K050790 ยท CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
SPOTCHEM II LDH TEST
| Applicant | Arkray, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Jun 6, 2005 |
| Received | Mar 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050790
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.