510(k) K971919 ยท LCP Assay, Glycosylated Hemoglobin
EZCHEK/HBA BLOOD COLLECTION KIT
| Applicant | Flexsite Diagnostics, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 5, 1997 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971919
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.