EMIT-TOX SERUM CALIBRATORS
FDA 510(k) clearance K790735 · decided 1979-05-03
Clearance details
- K-number
- K790735
- Device name
- EMIT-TOX SERUM CALIBRATORS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-16
- Decision date
- 1979-05-03
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DKB
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Seru recall (Z-0665-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-01-10 |