510(k) K852391 ยท CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 1, 1985 |
| Received | Jun 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852391
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.