FDA.reportPublic FDA data

510(k) DEN040012

Device
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
Applicant
Affymetrix, Inc.
510(k) number
DEN040012
Product code
NSU
Decision
Unknown (DENG)
Decision date
2004-12-23
Date received
2004-11-03
Regulation
862.2570
Classification name
Instrumentation For Clinical Multiplex Test Systems
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
ROBERT LIPSHUTZ
Address
3380 Central Expy. Santa Clara CA US 95051 95051

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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