510(k) K972666 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 11, 1997 |
| Received | Jul 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972666
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.