510(k) K861221 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Apr 24, 1986 |
| Received | Apr 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861221
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.