Clearance Summary
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN received FDA 510(k) clearance under submission number K083729, sponsored by Aniara Diagnostica, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-05-08.
- Submission: K083729
- Applicant / Sponsor: Aniara Diagnostica, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 2009-05-08
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.