510(k) K942958 ยท JHW U.V. Method, Cpk Isoenzymes
CREATINE KINASE MB DETERMINATION (UV)
| Applicant | Biochemical Trade, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 21, 1994 |
| Received | Jun 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942958
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Medtest Holdings, Inc. The Pointe Scientific CK-MB Isoenzyme Control
Pointe Scientific CK-MB Level II Control,
C7562-12 Control Kit Terminated |
JHW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.