510(k) K860453 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 19, 1986 |
| Received | Feb 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860453
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.