510(k) K112015 ยท LCP Assay, Glycosylated Hemoglobin
PREMIER HB9210 HBA1C ANALYZER
| Applicant | Primus Corporation Dba Trinity Biotech, Kansas City MO, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Jul 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112015
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.