510(k) K061377 ยท MSJ Apolipoproteins
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Mar 28, 2007 |
| Received | May 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061377
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.