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FDA 510(k)

MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

K-Number: K080995 · 2008-07-30

ApplicantAffymetrix, Inc.
Decision Date2008-07-30
Product CodeNSU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Affymetrix, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K080995. The device is classified under product code NSU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM?

MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Affymetrix, Inc.. The 510(k) number is K080995.

When did MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM received FDA 510(k) clearance on 2008-07-30, under 510(k) number K080995.

Who is the listed applicant for MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM?

The FDA 510(k) record lists Affymetrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM?

The FDA product code for MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM is NSU.

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Other records listing Affymetrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103112AFFYMETRIX GENE PROFILING REAGENTS

Related Devices (Code: NSU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163652ePlex InstrumentGenmark Diagnostics, IncorporatedK121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PLuminex Corp.K110786ESENSOR WARFARIN SENSITIVITY SALIVA TESTGenMark Diagnostics, Inc.K093128ILLUMINA BEADXPRESS SYSTEMIllumina, Inc.K082562APPLIED BIOSYSTEMS 7500 FAST DXApplied Biosystems, Inc.K073506LUMINEX LX 100/200 INSTRUMENTLuminex Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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