510(k) K820768 ยท CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
COLORIMETRIC LDH REAGENT SET
| Applicant | Biorent Diagnostic, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 14, 1982 |
| Received | Mar 22, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820768
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.