510(k) K912603 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
REP ALP-15, 8, & 4 KITS
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | Jun 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912603
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.