510(k) K780635 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
REAGENT SET HDL CHOLESTEROL
| Applicant | Boehringer Mannheim Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, May 19, 1978 |
| Received | Apr 17, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780635
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.