Clearance Summary
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT received FDA 510(k) clearance under submission number K110880, sponsored by Maine Standards Company, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-07-05.
- Submission: K110880
- Applicant / Sponsor: Maine Standards Company, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2011-07-05
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.