510(k) K881229 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, May 27, 1988 |
| Received | Mar 22, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881229
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.