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FDA 510(k)

HMA URIC ACID TEST

K-Number: K781004 · 1978-07-27

ApplicantHycel, Inc.
Decision Date1978-07-27
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HMA URIC ACID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K781004. 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 HMA URIC ACID TEST?

HMA URIC ACID TEST is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Hycel, Inc.. The 510(k) number is K781004.

When did HMA URIC ACID TEST receive FDA 510(k) clearance?

HMA URIC ACID TEST received FDA 510(k) clearance on 1978-07-27, under 510(k) number K781004.

Who is the listed applicant for HMA URIC ACID TEST?

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

What is the FDA product code for HMA URIC ACID TEST?

The FDA product code for HMA URIC ACID TEST is KNK.

Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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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