Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) received FDA 510(k) clearance under submission number K970643, 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: K970643
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1260
- Decision date: 1997-03-18
Classification & Regulation
This clearance is catalogued under FDA product code CHP and 21 CFR 862.1260, within the Clinical Chemistry review panel as a Class I device.