Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) received FDA 510(k) clearance under submission number K964308, 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: K964308
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1715
- Decision date: 1996-11-27
Classification & Regulation
This clearance is catalogued under FDA product code KHQ and 21 CFR 862.1715, within the Clinical Chemistry review panel as a Class II device.