Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) received FDA 510(k) clearance under submission number K964720, 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 1997-02-04.
- Submission: K964720
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1300
- Decision date: 1997-02-04
Classification & Regulation
This clearance is catalogued under FDA product code CGJ and 21 CFR 862.1300, within the Clinical Chemistry review panel as a Class I device.