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FDA 510(k)

SERALYZER URIC ACID REAGENT STRIPS -

K-Number: K800848 · 1980-04-24

ApplicantMiles Laboratories, Inc.
Decision Date1980-04-24
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER URIC ACID REAGENT STRIPS - is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800848. 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 SERALYZER URIC ACID REAGENT STRIPS -?

SERALYZER URIC ACID REAGENT STRIPS - is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800848.

When did SERALYZER URIC ACID REAGENT STRIPS - receive FDA 510(k) clearance?

SERALYZER URIC ACID REAGENT STRIPS - received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800848.

Who is the listed applicant for SERALYZER URIC ACID REAGENT STRIPS -?

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

What is the FDA product code for SERALYZER URIC ACID REAGENT STRIPS -?

The FDA product code for SERALYZER URIC ACID REAGENT STRIPS - is KNK.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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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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