RAPIDONE - COCAINE TEST
FDA 510(k) clearance K990822 · decided 1999-07-15
Clearance details
- K-number
- K990822
- Device name
- RAPIDONE - COCAINE TEST
- Applicant
- American Bio Medica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-11
- Decision date
- 1999-07-15
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- 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.