510(k) K873399 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
TITAN GEL CPK REP SYSTEM
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 20, 1987 |
| Received | Aug 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873399
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.