510(k) K984288 ยท DLZ Enzyme Immunoassay, Phenobarbital
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 26, 1999 |
| Received | Dec 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384
VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 25 Terminated |
DLZ | None listed |
| Apr 19, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384.
For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. Terminated |
DLZ | None listed |
| Feb 28, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHBR Slides, REF 822 1384
--- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wy Terminated |
DLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.