MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM— 510(k) K080995

Name: FDA 510(k) clearance K080995
Creator: U.S. Food and Drug Administration
Published: 2008-07-30

Substantially Equivalent

Affymetrix, Inc.

FDA 510(k) clearance K080995 for MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM, Substantially Equivalent on 2008-07-30. Applicant: Affymetrix, Inc.. Device class: 2.

Clearance details

Applicant: Affymetrix, Inc.
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2008-04-07
Decision date: 2008-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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