510(k) K853943 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CRITIC C LEVEL I & II
| Applicant | Dimension Diagnostics, St. Peters MO, US |
| Decision | Substantially Equivalent, Dec 23, 1985 |
| Received | Sep 24, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853943
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.