EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
FDA 510(k) clearance K913123 · decided 1991-09-19
Clearance details
- K-number
- K913123
- Device name
- EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-15
- Decision date
- 1991-09-19
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KLS
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immu recall (Z-2298-2016) | Siemens Healthcare Diagnostics, Inc. | 2016-07-28 |
| ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic recall (Z-2299-2016) | Siemens Healthcare Diagnostics, Inc. | 2016-07-28 |