Clearance Summary
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 received FDA 510(k) clearance under submission number K090283, sponsored by Genchem, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-06-05.
- Submission: K090283
- Applicant / Sponsor: Genchem, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2009-06-05
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.