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FDA 510(k)

ROCHE REAGENT FOR URIC ACID--MODIFICATION

K-Number: K922762 · 1992-07-09

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-07-09
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR URIC ACID--MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-07-09 under 510(k) number K922762. 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 ROCHE REAGENT FOR URIC ACID--MODIFICATION?

ROCHE REAGENT FOR URIC ACID--MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-07-09. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K922762.

When did ROCHE REAGENT FOR URIC ACID--MODIFICATION receive FDA 510(k) clearance?

ROCHE REAGENT FOR URIC ACID--MODIFICATION received FDA 510(k) clearance on 1992-07-09, under 510(k) number K922762.

Who is the listed applicant for ROCHE REAGENT FOR URIC ACID--MODIFICATION?

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

What is the FDA product code for ROCHE REAGENT FOR URIC ACID--MODIFICATION?

The FDA product code for ROCHE REAGENT FOR URIC ACID--MODIFICATION is KNK.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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 LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB 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 Saic

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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