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FDA 510(k)

COLORIMETRIC URIC ACID REAGENT SET

K-Number: K820632 · 1982-03-25

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-03-25
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC URIC ACID REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-03-25 under 510(k) number K820632. 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 COLORIMETRIC URIC ACID REAGENT SET?

COLORIMETRIC URIC ACID REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-03-25. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K820632.

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

COLORIMETRIC URIC ACID REAGENT SET received FDA 510(k) clearance on 1982-03-25, under 510(k) number K820632.

Who is the listed applicant for COLORIMETRIC URIC ACID REAGENT SET?

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

What is the FDA product code for COLORIMETRIC URIC ACID REAGENT SET?

The FDA product code for COLORIMETRIC URIC ACID REAGENT SET is KNK.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823211CK-UV REAGENTK823060HEMOGLOBIN REAGENTK822494OPTIMIZED UV-GPT REAGENT SETK822493OPTIMIZED UV-GOT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SET

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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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