510(k) K801226 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
TRIGLYCERIDES FOR SMA AND AAII
| Applicant | Reagents Applications, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 20, 1980 |
| Received | May 22, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801226
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.