510(k) K981373 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
ALKPHASE-B ASSAY KIT
| Applicant | Metra Biosystems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, May 27, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2016 | Diagnostic Hybrids, Inc. MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. Terminated |
CIN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.