510(k) K972265 ยท LCP Assay, Glycosylated Hemoglobin
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Sep 25, 1997 |
| Received | Jun 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972265
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.