RAPIDONE-BUPRENORPHINE TEST
FDA 510(k) clearance K060760 · decided 2006-08-07
Clearance details
- K-number
- K060760
- Device name
- RAPIDONE-BUPRENORPHINE TEST
- Applicant
- American Bio Medica Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-21
- Decision date
- 2006-08-07
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.