510(k) K920449 ยท LCP Assay, Glycosylated Hemoglobin
POINTE 750 GLYCOMETER
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jul 28, 1992 |
| Received | Feb 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920449
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.