COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
FDA 510(k) clearance K874808 · decided 1988-02-18
Clearance details
- K-number
- K874808
- Device name
- COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-23
- Decision date
- 1988-02-18
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.