510(k) K912455 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Aug 12, 1991 |
| Received | Jun 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912455
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.