510(k) K020625 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, May 6, 2002 |
| Received | Feb 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020625
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.