EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
FDA 510(k) clearance K931536 · decided 1993-05-11
Clearance details
- K-number
- K931536
- Device name
- EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-29
- Decision date
- 1993-05-11
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JXM
- Device class
- 2
- Regulation number
- 862.3170
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.