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FDA 510(k)

URS-1B (BLOOD TEST)

K-Number: K023297 · 2003-03-06

ApplicantTeco Diagnostics
Decision Date2003-03-06
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

URS-1B (BLOOD TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2003-03-06 under 510(k) number K023297. 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 URS-1B (BLOOD TEST)?

URS-1B (BLOOD TEST) is a medical device that received FDA 510(k) clearance on 2003-03-06. The listed applicant is Teco Diagnostics. The 510(k) number is K023297.

When did URS-1B (BLOOD TEST) receive FDA 510(k) clearance?

URS-1B (BLOOD TEST) received FDA 510(k) clearance on 2003-03-06, under 510(k) number K023297.

Who is the listed applicant for URS-1B (BLOOD TEST)?

The FDA 510(k) record lists Teco Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URS-1B (BLOOD TEST)?

The FDA product code for URS-1B (BLOOD TEST) is JIO.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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 SaicK040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISDirui Industrial Co., Ltd.

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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