Clearance Summary
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM received FDA 510(k) clearance under submission number DEN040012, sponsored by Affymetrix, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-12-23.
- Submission: DEN040012
- Applicant / Sponsor: Affymetrix, Inc.
- Clearance pathway: Post-NSE
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.2570
- Decision date: 2004-12-23
Classification & Regulation
This clearance is catalogued under FDA product code NSU and 21 CFR 862.2570, within the Clinical Chemistry review panel as a Class II device.