510(k) K031947 ยท KQO Automated Urinalysis System
BAYER CLINITEK STATUS ANALYZER
| Applicant | Bayer Healthcare, LLC, Medfield MA, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Jun 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031947
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.