BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70— 510(k) K083801
Substantially EquivalentKhn Solutions, LLC
FDA 510(k) clearance K083801 for BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70, Substantially Equivalent on 2009-03-19. Applicant: Khn Solutions, LLC. Device class: 1.
Clearance details
- Applicant
- Khn Solutions, LLC
- 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
- Deer Field, IL, US
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