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FDA 510(k)

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

K-Number: K043202 · 2004-12-23

ApplicantOlympus America, Inc.
Decision Date2004-12-23
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 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 2004-12-23 under 510(k) number K043202. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279?

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Olympus America, Inc.. The 510(k) number is K043202.

When did OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 receive FDA 510(k) clearance?

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 received FDA 510(k) clearance on 2004-12-23, under 510(k) number K043202.

Who is the listed applicant for OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279?

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 CREATINE KINASE REAGENT OSR6179/OSR6279?

The FDA product code for OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 is CGS.

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Other records listing Olympus America, Inc. as applicant

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Related Devices (Code: CGS)

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.

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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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