510(k) K000885 ยท LCP Assay, Glycosylated Hemoglobin
DRX HBA1C - FOR PRESCRIPTION HOME USE
| Applicant | Metrika, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 26, 2000 |
| Received | Mar 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000885
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.