meddevicedb.com FDA Device Reference

CYTOSCAN(R) DX

DEN130018 Class II Post-NSE
Decision Date
2014-01-17
Sponsor / Applicant
Affymetrix, Inc.

Technical Specification

510(k) Submission ID DEN130018
Product Code PFX
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5920
Decision Date 2014-01-17
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

CYTOSCAN(R) DX received FDA 510(k) clearance under submission number DEN130018, sponsored by Affymetrix, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2014-01-17.

Classification & Regulation

This clearance is catalogued under FDA product code PFX and 21 CFR 866.5920, within the Immunology review panel as a Class II device.