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FDA 510(k)

LINEAR ENZMATIC URIC ACID SYSTEM

K-Number: K831398 · 1983-06-08

ApplicantSimmler, Inc.
Decision Date1983-06-08
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINEAR ENZMATIC URIC ACID SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831398. 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 LINEAR ENZMATIC URIC ACID SYSTEM?

LINEAR ENZMATIC URIC ACID SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Simmler, Inc.. The 510(k) number is K831398.

When did LINEAR ENZMATIC URIC ACID SYSTEM receive FDA 510(k) clearance?

LINEAR ENZMATIC URIC ACID SYSTEM received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831398.

Who is the listed applicant for LINEAR ENZMATIC URIC ACID SYSTEM?

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

What is the FDA product code for LINEAR ENZMATIC URIC ACID SYSTEM?

The FDA product code for LINEAR ENZMATIC URIC ACID SYSTEM is KNK.

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Other records listing Simmler, 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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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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