510(k) K915732 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 15, 1992 |
| Received | Dec 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915732
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.