510(k) K972580 ยท JMM Column Chromatography & Color Development, Hydroxyproline
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 22, 1997 |
| Received | Jul 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972580
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.