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FDA 510(k)

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

K-Number: K062862 · 2007-04-06

ApplicantOlympus America, Inc.
Decision Date2007-04-06
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 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 2007-04-06 under 510(k) number K062862. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS URIC ACID REAGENT, MODEL OSR6X98?

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Olympus America, Inc.. The 510(k) number is K062862.

When did OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 receive FDA 510(k) clearance?

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 received FDA 510(k) clearance on 2007-04-06, under 510(k) number K062862.

Who is the listed applicant for OLYMPUS URIC ACID REAGENT, MODEL OSR6X98?

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 URIC ACID REAGENT, MODEL OSR6X98?

The FDA product code for OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 is KNK.

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073490OLYMPUS IGG REAGENTK073487OLYMPUS IGM REAGENTK073489OLYMPUS IGA REAGENTK063804OLYMPUS TRIGLYCERIDE TEST SYSTEM

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories SaicK012038JAS URIC ACID LIQUID REAGENTJas Diagnostics, Inc.

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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