Clearance Summary
H.P.T. HOME PREG. TEST KIT & A.P.T. received FDA 510(k) clearance under submission number K834474, sponsored by Biomedical Research & Development Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1984-09-28.
- Submission: K834474
- Applicant / Sponsor: Biomedical Research & Development Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1984-09-28
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.