Clearance Summary
DBEST ONE STEP OCCULT BLOOD TEST KITS received FDA 510(k) clearance under submission number K071242, sponsored by Ameritek USA, 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 2008-03-06.
- Submission: K071242
- Applicant / Sponsor: Ameritek USA, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2008-03-06
Classification & Regulation
This clearance is catalogued under FDA product code KHE and 21 CFR 864.6550, within the Hematology review panel as a Class II device.