EMIT-STM OPIATE ASSAY
FDA 510(k) clearance K802615 · decided 1980-10-31
Clearance details
- K-number
- K802615
- Device name
- EMIT-STM OPIATE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-20
- Decision date
- 1980-10-31
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- DJE
- Device class
- 2
- Regulation number
- 862.3830
- 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
No recalls on record reference this clearance.