Clearance Summary
AMER. BIO-SCIENCE LAB T3 REAGENTS received FDA 510(k) clearance under submission number K842590, sponsored by American Bio-Science Laboratories. 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 1984-08-10.
- Submission: K842590
- Applicant / Sponsor: American Bio-Science Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1984-08-10
Classification & Regulation
This clearance is catalogued under FDA product code CDP and 21 CFR 862.1710, within the Clinical Chemistry review panel as a Class II device.