Clearance Summary
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) received FDA 510(k) clearance under submission number K972133, 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 1997-06-24.
- Submission: K972133
- Applicant / Sponsor: Johnson & Johnson Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1620
- Decision date: 1997-06-24
Classification & Regulation
This clearance is catalogued under FDA product code JLS and 21 CFR 862.1620, within the Clinical Chemistry review panel as a Class I device.