510(k) K874757 ยท DIF Drug Mixture Control Materials
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Feb 2, 1988 |
| Received | Nov 18, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874757
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.