510(k) K962235 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
VITROS SPECIALTY DILUENT
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 26, 1996 |
| Received | Jun 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY Terminated |
JJE | None listed |
| Apr 28, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.