510(k) K913130 ยท KHO Fluorometer, For Clinical Use
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Jul 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913130
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.