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FDA 510(k)

OLYMPUS IGG REAGENT

K-Number: K073490 · 2008-02-11

ApplicantOlympus America, Inc.
Decision Date2008-02-11
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS IGG REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2008-02-11 under 510(k) number K073490. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS IGG REAGENT?

OLYMPUS IGG REAGENT is a medical device that received FDA 510(k) clearance on 2008-02-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K073490.

When did OLYMPUS IGG REAGENT receive FDA 510(k) clearance?

OLYMPUS IGG REAGENT received FDA 510(k) clearance on 2008-02-11, under 510(k) number K073490.

Who is the listed applicant for OLYMPUS IGG REAGENT?

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

What is the FDA product code for OLYMPUS IGG REAGENT?

The FDA product code for OLYMPUS IGG REAGENT is CFN.

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Other records listing Olympus America, Inc. as applicant

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Official Source

View on FDA Database →

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

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