Clearance Summary
A.QC HCT LEVEL 1 AND 2 received FDA 510(k) clearance under submission number K893562, sponsored by Johnson & Johnson Professionals, 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 1989-07-14.
- Submission: K893562
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1989-07-14
Classification & Regulation
This clearance is catalogued under FDA product code GLK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.