510(k) K964346 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
PARAMAX TRIGLYCERID REAGENT
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Oct 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964346
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.