Clearance Summary
KING DIAGNOSTICS GAMMA GT REAGENT received FDA 510(k) clearance under submission number K923091, sponsored by King 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 1992-09-09.
- Submission: K923091
- Applicant / Sponsor: King Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1992-09-09
Classification & Regulation
This clearance is catalogued under FDA product code JPZ and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.