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FDA 510(k)

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

K-Number: K040703 · 2004-08-26

ApplicantDirui Industrial Co., Ltd.
Decision Date2004-08-26
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Dirui Industrial Co., Ltd.. It received FDA 510(k) clearance on 2004-08-26 under 510(k) number K040703. 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 URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS?

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 2004-08-26. The listed applicant is Dirui Industrial Co., Ltd.. The 510(k) number is K040703.

When did URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS receive FDA 510(k) clearance?

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS received FDA 510(k) clearance on 2004-08-26, under 510(k) number K040703.

Who is the listed applicant for URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS?

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

What is the FDA product code for URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS?

The FDA product code for URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS is JIO.

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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.K082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERSUrit Medical Electronic Co., Ltd.K083724WIENER LAB. URINE STRIP 10 AND 11Wiener Laboratorios SaicK023297URS-1B (BLOOD TEST)Teco Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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