510(k) K961412 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 18, 1996 |
| Received | Apr 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961412
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.