510(k) K011113 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
| Applicant | Sebia, Chelsea MI, US |
| Decision | Substantially Equivalent, Jun 13, 2001 |
| Received | Apr 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011113
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.