510(k) K821981 ยท JJT Enzyme Controls (Assayed And Unassayed)
TITAN GEL CPK/LDH ISOENZYME CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 22, 1982 |
| Received | Jul 6, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821981
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.