510(k) K880039 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 24, 1988 |
| Received | Jan 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880039
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.