MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM


Device Classification Name

instrumentation for clinical multiplex test systems

510(k) Number K080995
Device Name MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
Applicant
Affymetrix, Inc.
3420 central expressway
santa clara, 
CA 
95051

Applicant Contact maureen j mende
Correspondent
Affymetrix, Inc.
3420 central expressway
santa clara, 
CA 
95051

Correspodent Contact maureen j mende
Regulation Number 862.2570
Classification Product Code
NSU  
Date Received 04/07/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No