510(k) K930810 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 11, 1994 |
| Received | Feb 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930810
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.