510(k) K091400 ยท LCP Assay, Glycosylated Hemoglobin
MODIFICATION TO AVIE A1C TEST SYSTEM
| Applicant | Mec Dynamics Corp, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 11, 2009 |
| Received | May 12, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091400
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.