510(k) K770971 ยท JJT Enzyme Controls (Assayed And Unassayed)
CARDIOZYME CK-CONTROL ABNORMAL
| Applicant | Dade, Baxter Travenol Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 4, 1977 |
| Received | May 31, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770971
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.