VALIDATE Heparin Calibration Verification/Linearity Test Kit
FDA 510(k) clearance K163498 · decided 2017-03-16
Clearance details
- K-number
- K163498
- Device name
- VALIDATE Heparin Calibration Verification/Linearity Test Kit
- Applicant
- Maine Standards Company, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-12-13
- Decision date
- 2017-03-16
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cumberland Foreside, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.