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FDA 510(k)

COULTER URIC ACID REAGENT

K-Number: K897161 · 1990-03-01

ApplicantCoulter Electronics, Inc.
Decision Date1990-03-01
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER URIC ACID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1990-03-01 under 510(k) number K897161. 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 COULTER URIC ACID REAGENT?

COULTER URIC ACID REAGENT is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K897161.

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

COULTER URIC ACID REAGENT received FDA 510(k) clearance on 1990-03-01, under 510(k) number K897161.

Who is the listed applicant for COULTER URIC ACID REAGENT?

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

What is the FDA product code for COULTER URIC ACID REAGENT?

The FDA product code for COULTER URIC ACID REAGENT is KNK.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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