VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit— 510(k) K162705
Substantially EquivalentMaine Standards Company, LLC
FDA 510(k) clearance K162705 for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit, Substantially Equivalent on 2017-01-05. Applicant: Maine Standards Company, LLC. Device class: 2.
Clearance details
- Applicant
- Maine Standards Company, LLC
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cumberland Foreside, ME, US
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