510(k) K111128 ยท LCP Assay, Glycosylated Hemoglobin
LABONACHECK A1C
| Applicant | Ceragem International, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 13, 2012 |
| Received | Apr 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111128
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.