Clearance Summary
BTA STAT TEST PRESCRIPTION HOME USE received FDA 510(k) clearance under submission number K974845, sponsored by Bard Diagnostic Sciences,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-12-08.
- Submission: K974845
- Applicant / Sponsor: Bard Diagnostic Sciences,Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1998-12-08
Classification & Regulation
This clearance is catalogued under FDA product code MMW and 21 CFR 866.6010, within the Immunology review panel as a Class II device.