RAPIDONE-AMPHETAMINE TEST
FDA 510(k) clearance K992452 · decided 1999-10-18
Clearance details
- K-number
- K992452
- Device name
- RAPIDONE-AMPHETAMINE TEST
- Applicant
- American Bio Medica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-22
- Decision date
- 1999-10-18
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DOD
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.