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FDA 510(k)

OLYMPUS URIC ACID REAGENT

K-Number: K955752 · 1996-01-31

ApplicantOlympus America, Inc.
Decision Date1996-01-31
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS URIC ACID 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 1996-01-31 under 510(k) number K955752. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS URIC ACID REAGENT?

OLYMPUS URIC ACID REAGENT is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Olympus America, Inc.. The 510(k) number is K955752.

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

OLYMPUS URIC ACID REAGENT received FDA 510(k) clearance on 1996-01-31, under 510(k) number K955752.

Who is the listed applicant for OLYMPUS URIC ACID 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 URIC ACID REAGENT?

The FDA product code for OLYMPUS URIC ACID REAGENT is CDO.

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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 ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, 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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