Clearance Summary
COATEST(R) APC(TM) RESISTANCE received FDA 510(k) clearance under submission number K945940, sponsored by Axis-Shield Doc AS. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1995-08-07.
- Submission: K945940
- Applicant / Sponsor: Axis-Shield Doc AS
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 1995-08-07
Classification & Regulation
This clearance is catalogued under FDA product code GGW and 21 CFR 864.7925, within the Hematology review panel as a Class II device.