EMIT IMIPRAMINE ASSAY
FDA 510(k) clearance K844951 · decided 1985-06-28
Clearance details
- K-number
- K844951
- Device name
- EMIT IMIPRAMINE ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-20
- Decision date
- 1985-06-28
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- LFG
- Device class
- 2
- Regulation number
- 862.3910
- 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
No recalls on record reference this clearance.