Clearance Summary
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 received FDA 510(k) clearance under submission number K072246, sponsored by Maine Standards Co.. 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 2007-09-14.
- Submission: K072246
- Applicant / Sponsor: Maine Standards Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2007-09-14
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.