BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS— 510(k) K060761
Substantially EquivalentAkers Biosciences, Inc.
FDA 510(k) clearance K060761 for BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS, Substantially Equivalent on 2006-04-28. Applicant: Akers Biosciences, Inc.. Device class: 1.
Clearance details
- Applicant
- Akers Biosciences, Inc.
- Product code
- Code DJZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.3050
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Thorofare, NJ, US
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