510(k) K960546 ยท KQO Automated Urinalysis System
CLINITEK 50 URINE CHEMISTRY ANALYZER
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Jun 12, 1996 |
| Received | Feb 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Bayer Healthcare LLC Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). Terminated |
KQO | None listed |
| Jun 21, 2003 | Bayer HealthCare LLC, Diagnostics Div Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.] Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.