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FDA 510(k)

AFFYMETRIX GENE PROFILING REAGENTS

K-Number: K103112 · 2011-05-04

ApplicantAffymetrix, Inc.
Decision Date2011-05-04
Product CodeOVA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFYMETRIX GENE PROFILING REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Affymetrix, Inc.. It received FDA 510(k) clearance on 2011-05-04 under 510(k) number K103112. The device is classified under product code OVA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFYMETRIX GENE PROFILING REAGENTS?

AFFYMETRIX GENE PROFILING REAGENTS is a medical device that received FDA 510(k) clearance on 2011-05-04. The listed applicant is Affymetrix, Inc.. The 510(k) number is K103112.

When did AFFYMETRIX GENE PROFILING REAGENTS receive FDA 510(k) clearance?

AFFYMETRIX GENE PROFILING REAGENTS received FDA 510(k) clearance on 2011-05-04, under 510(k) number K103112.

Who is the listed applicant for AFFYMETRIX GENE PROFILING REAGENTS?

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 AFFYMETRIX GENE PROFILING REAGENTS?

The FDA product code for AFFYMETRIX GENE PROFILING REAGENTS is OVA.

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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.

K080995MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

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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