510(k) K041764 ยท LCP Assay, Glycosylated Hemoglobin
THE VITROS 5,1 FS CHEMISTRY SYSTEM
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Sep 9, 2004 |
| Received | Jun 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041764
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.