OLYMPUS IGG REAGENT— 510(k) K073490

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K073490 for OLYMPUS IGG REAGENT, Substantially Equivalent on 2008-02-11. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2007-12-12
Decision date: 2008-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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