Clearance Summary
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE received FDA 510(k) clearance under submission number K093297, sponsored by Epocal, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2010-06-09.
- Submission: K093297
- Applicant / Sponsor: Epocal, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1450
- Decision date: 2010-06-09
Classification & Regulation
This clearance is catalogued under FDA product code KHP and 21 CFR 862.1450, within the Clinical Chemistry review panel as a Class I device.