510(k) K063164 ยท LDJ Enzyme Immunoassay, Cannabinoids
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 28, 2006 |
| Received | Oct 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2014 | Ortho-Clinical Diagnostics VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Terminated |
DKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.