Clearance Summary
SPECIALTY ASSAYED CONTROL-2 received FDA 510(k) clearance under submission number K100103, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2010-12-15.
- Submission: K100103
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2010-12-15
Classification & Regulation
This clearance is catalogued under FDA product code GGC and 21 CFR 864.5425, within the Hematology review panel as a Class II device.