510(k) K062165 ยท DIS Enzyme Immunoassay, Barbiturate
VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 5, 2007 |
| Received | Jul 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier I
in vitro diagnostic Terminated |
DIF | None listed |
| Sep 22, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic Terminated |
DIF | None listed |
| Sep 22, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic Terminated |
DIF | None listed |
| Sep 22, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic Terminated |
DIF | None listed |
| Sep 22, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic Terminated |
DIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.