510(k) K911178 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
| Applicant | Analytical Control Systems, Inc., Fishers IN, US |
| Decision | Substantially Equivalent, May 1, 1991 |
| Received | Mar 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911178
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.