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FDA 510(k)

BIOTROL URIC ACID ENZYMATIQUE TRINDER

K-Number: K883428 · 1988-09-13

ApplicantBiotrol, USA, Inc.
Decision Date1988-09-13
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL URIC ACID ENZYMATIQUE TRINDER is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883428. 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 BIOTROL URIC ACID ENZYMATIQUE TRINDER?

BIOTROL URIC ACID ENZYMATIQUE TRINDER is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K883428.

When did BIOTROL URIC ACID ENZYMATIQUE TRINDER receive FDA 510(k) clearance?

BIOTROL URIC ACID ENZYMATIQUE TRINDER received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883428.

Who is the listed applicant for BIOTROL URIC ACID ENZYMATIQUE TRINDER?

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

What is the FDA product code for BIOTROL URIC ACID ENZYMATIQUE TRINDER?

The FDA product code for BIOTROL URIC ACID ENZYMATIQUE TRINDER is KNK.

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Other records listing Biotrol, USA, Inc. as applicant

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K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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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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