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FDA 510(k)

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

K-Number: K082811 · 2009-09-11

ApplicantUrit Medical Electronic Co., Ltd.
Decision Date2009-09-11
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Urit Medical Electronic Co., Ltd.. It received FDA 510(k) clearance on 2009-09-11 under 510(k) number K082811. The device is classified under product code JIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS?

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS is a medical device that received FDA 510(k) clearance on 2009-09-11. The listed applicant is Urit Medical Electronic Co., Ltd.. The 510(k) number is K082811.

When did URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS receive FDA 510(k) clearance?

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS received FDA 510(k) clearance on 2009-09-11, under 510(k) number K082811.

Who is the listed applicant for URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS?

The FDA 510(k) record lists Urit Medical Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS?

The FDA product code for URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS is JIO.

Related Clinical Trials

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.

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Other records listing Urit Medical Electronic Co., Ltd. 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.

K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

Related Devices (Code: JIO)

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.

K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd.K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLCK111221MISSION U500 URINE ANALYZERACON Laboratories, Inc.K083724WIENER LAB. URINE STRIP 10 AND 11Wiener Laboratorios SaicK040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISDirui Industrial Co., Ltd.K023297URS-1B (BLOOD TEST)Teco Diagnostics

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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