510(k) K913123 ยท KLS Enzyme Immunoassay, Theophylline
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | Jul 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2017 | Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Theophylline
Product Usage:
The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or pl Terminated |
KLS | None listed |
| Jul 28, 2016 | Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. Terminated |
KLS | None listed |
| Jul 28, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA Chemistry Systems.
Copi Terminated |
KLS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.