510(k) K011528 ยท DLZ Enzyme Immunoassay, Phenobarbital
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | May 17, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2013 | Siemens Healthcare Diagnostics, Inc. Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Terminated |
DLZ | None listed |
| Jan 10, 2013 | Siemens Healthcare Diagnostics, Inc. Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL).
Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human s Terminated |
DLZ | None listed |
| Oct 10, 2012 | Siemens Healthcare Diagnostics, Inc. Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)
Product Usage: Enzyme n Immunoassay, Phenobarbital Terminated |
DLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.