Clearance Summary
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE received FDA 510(k) clearance under submission number K884623, sponsored by Safe-Tec Clinical 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 1988-12-01.
- Submission: K884623
- Applicant / Sponsor: Safe-Tec Clinical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6150
- Decision date: 1988-12-01
Classification & Regulation
This clearance is catalogued under FDA product code GIO and 21 CFR 864.6150, within the Hematology review panel as a Class I device.