510(k) K063720 ยท DHA System, Test, Human Chorionic Gonadotropin
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 9, 2007 |
| Received | Dec 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2016 | Ortho-Clinical Diagnostics 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack
(Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrator Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.