510(k) K981978 ยท MRR System, Test, Low Density, Lipoprotein
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jul 22, 1998 |
| Received | Jun 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981978
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.