510(k) K993031 ยท DLZ Enzyme Immunoassay, Phenobarbital
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2013 | Abbott Laboratories, Inc Clinical Chemistry Phenobarbital, list number 1E08 Terminated |
DLZ | None listed |
| Jan 9, 2007 | Abbott Laboratories Inc. Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division Terminated |
DLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.