510(k) K921578 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
TITAN GEL ALKALINE PHOSPHATASE (HR)
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Sep 23, 1992 |
| Received | Apr 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921578
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.