VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit— 510(k) K153712
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K153712 for VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit, Substantially Equivalent on 2016-01-28. Applicant: Radiometer America, Inc.. Device class: 1.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code JJY
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