510(k) K963085 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
| Applicant | International Enzymes, Inc., San Marcos CA, US |
| Decision | Substantially Equivalent, Aug 20, 1996 |
| Received | Aug 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963085
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.