VALIDATE Anemia Calibration Verification/ Linearity Test Kit— 510(k) K142964
Substantially EquivalentMaine Standards Company, LLC
FDA 510(k) clearance K142964 for VALIDATE Anemia Calibration Verification/ Linearity Test Kit, Substantially Equivalent on 2015-04-30. Applicant: Maine Standards Company, LLC. Device class: 1.
Clearance details
- Applicant
- Maine Standards Company, LLC
- 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
- Cumberland Foreside, ME, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.