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FDA 510(k)

URIC ACID RAPID STAT KIT

K-Number: K780827 · 1978-06-13

ApplicantPierce Chemical Co.
Decision Date1978-06-13
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID RAPID STAT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780827. 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 URIC ACID RAPID STAT KIT?

URIC ACID RAPID STAT KIT is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Pierce Chemical Co.. The 510(k) number is K780827.

When did URIC ACID RAPID STAT KIT receive FDA 510(k) clearance?

URIC ACID RAPID STAT KIT received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780827.

Who is the listed applicant for URIC ACID RAPID STAT KIT?

The FDA 510(k) record lists Pierce Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIC ACID RAPID STAT KIT?

The FDA product code for URIC ACID RAPID STAT KIT is KNK.

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Other records listing Pierce Chemical Co. 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.

K895661GLYCOTEST II GLYHB ASSAY KITK831837CLINOVATIVE II DIAGNOSTIC KITK821360GLYCO-GEL TEST KITK820279GLYCO-GEL TEST KITK781897STAT KIT, MICROPROTEINK780825TRIGLYCERIDE C-37 RAPID STAT KIT

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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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