510(k) K802068 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
| Applicant | Beckman Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1980 |
| Received | Aug 27, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802068
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.