Clearance Summary
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED received FDA 510(k) clearance under submission number K021162, sponsored by Sigma Diagnostics, 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 2002-08-30.
- Submission: K021162
- Applicant / Sponsor: Sigma Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2002-08-30
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.