510(k) K910638 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Mar 11, 1991 |
| Received | Feb 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910638
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.