510(k) K030553 ยท LCP Assay, Glycosylated Hemoglobin
ARKIT HBA1C
| Applicant | Arkray, Inc., Wilmington NC, US |
| Decision | Substantially Equivalent, Sep 2, 2003 |
| Received | Feb 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030553
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.