510(k) K953097 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
OPUS T4 CONTROLS
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Aug 24, 1995 |
| Received | Jul 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953097
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.