ILLUMINA BEADXPRESS SYSTEM— 510(k) K093128

Substantially Equivalent

Illumina, Inc.

FDA 510(k) clearance K093128 for ILLUMINA BEADXPRESS SYSTEM, Substantially Equivalent on 2010-04-28. Applicant: Illumina, Inc.. Device class: 2.

Clearance details

Applicant: Illumina, Inc.
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2009-10-02
Decision date: 2010-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.