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FDA 510(k)

MILES AUTO METH DETERMIN OF URIC ACID IN URINE

K-Number: K924129 · 1992-09-22

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-09-22
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES AUTO METH DETERMIN OF URIC ACID IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-09-22 under 510(k) number K924129. 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 MILES AUTO METH DETERMIN OF URIC ACID IN URINE?

MILES AUTO METH DETERMIN OF URIC ACID IN URINE is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K924129.

When did MILES AUTO METH DETERMIN OF URIC ACID IN URINE receive FDA 510(k) clearance?

MILES AUTO METH DETERMIN OF URIC ACID IN URINE received FDA 510(k) clearance on 1992-09-22, under 510(k) number K924129.

Who is the listed applicant for MILES AUTO METH DETERMIN OF URIC ACID IN URINE?

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

What is the FDA product code for MILES AUTO METH DETERMIN OF URIC ACID IN URINE?

The FDA product code for MILES AUTO METH DETERMIN OF URIC ACID IN URINE is KNK.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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