AFFYMETRIX GENE PROFILING REAGENTS— 510(k) K103112

Name: FDA 510(k) clearance K103112
Creator: U.S. Food and Drug Administration
Published: 2011-05-04

Substantially Equivalent

Affymetrix, Inc.

FDA 510(k) clearance K103112 for AFFYMETRIX GENE PROFILING REAGENTS, Substantially Equivalent on 2011-05-04. Applicant: Affymetrix, Inc.. Device class: 2.

Clearance details

Applicant: Affymetrix, Inc.
Product code: Code OVA
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2010-10-21
Decision date: 2011-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood Shores, CA, US

Download summary PDF View on FDA.gov ↗

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