Clearance Summary
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) received FDA 510(k) clearance under submission number K971935, sponsored by B & D Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-10-01.
- Submission: K971935
- Applicant / Sponsor: B & D Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7140
- Decision date: 1997-10-01
Classification & Regulation
This clearance is catalogued under FDA product code JBP and 21 CFR 864.7140, within the Hematology review panel as a Class II device.