510(k) K121366 ยท LCP Assay, Glycosylated Hemoglobin
HEMOCUE HBA1C 501
| Applicant | Infopia Co, Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | May 7, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121366
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.