EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
FDA 510(k) clearance K821743 · decided 1982-07-02
Clearance details
- K-number
- K821743
- Device name
- EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-14
- Decision date
- 1982-07-02
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- LFG
- Device class
- 2
- Regulation number
- 862.3910
- 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 |
|---|---|---|
| Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. recall (Z-2881-2026) | Siemens Healthcare Diagnostics, Inc. | 2026-08-04 |