510(k) K961573 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 19, 1996 |
| Received | Apr 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961573
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.