DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
FDA 510(k) clearance K862218 · decided 1986-06-27
Clearance details
- K-number
- K862218
- Device name
- DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-11
- Decision date
- 1986-06-27
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- KLN
- Device class
- 2
- Regulation number
- 862.3250
- 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.