Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) received FDA 510(k) clearance under submission number K964310, sponsored by Johnson & Johnson Clinical Diagnostics, 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 1996-11-27.
- Submission: K964310
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1996-11-27
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.