Clearance Summary
THROMBO-SCREEN AT-111 KIT received FDA 510(k) clearance under submission number K770394, sponsored by Bay Area Hema. Onco. Clinic. & Res. L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1977-03-30.
- Submission: K770394
- Applicant / Sponsor: Bay Area Hema. Onco. Clinic. & Res. L
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7060
- Decision date: 1977-03-30
Classification & Regulation
This clearance is catalogued under FDA product code JBQ and 21 CFR 864.7060, within the Hematology review panel as a Class II device.