Clearance Summary
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 received FDA 510(k) clearance under submission number K934747, sponsored by R & D Batteries, 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 1993-12-03.
- Submission: K934747
- Applicant / Sponsor: R & D Batteries, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1993-12-03
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.