510(k) K980283 ยท KLT Enzyme Immunoassay, Carbamazepine
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Jan 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamaze Terminated |
KLT | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 Terminated |
KLT | None listed |
| Jul 16, 2005 | Ortho-Clinical Diagnostics Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. Terminated |
KLT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.