Clearance Summary
MONITEMP BLOOD PACK TEMP. MONITOR received FDA 510(k) clearance under submission number K800667, sponsored by Liquid Crystal Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-04-16.
- Submission: K800667
- Applicant / Sponsor: Liquid Crystal Products, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9700
- Decision date: 1980-04-16
Classification & Regulation
This clearance is catalogued under FDA product code KSE and 21 CFR 864.9700, within the Hematology review panel as a Class II device.