Clearance Summary
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK received FDA 510(k) clearance under submission number K971971, sponsored by Board of Directors, Albert Browne , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-07-10.
- Submission: K971971
- Applicant / Sponsor: Board of Directors, Albert Browne , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1998-07-10
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.