Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) received FDA 510(k) clearance under submission number K965142, 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 1997-03-18.
- Submission: K965142
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 1997-03-18
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.