510(k) K811150 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
URINE PREGNANCY TEST STANDARD/CONTR. PK
| Applicant | Mallinckrodt Critical Care, Mchenry IL, US |
| Decision | Substantially Equivalent, May 15, 1981 |
| Received | Apr 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811150
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.