510(k) K897169 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
| Applicant | Photec Diagnostics, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 23, 1990 |
| Received | Dec 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897169
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.