Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WIENER LAB. URINE STRIP 10 AND 11

K-Number: K083724 · 2009-09-02

ApplicantWiener Laboratorios Saic
Decision Date2009-09-02
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WIENER LAB. URINE STRIP 10 AND 11 is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratorios Saic. It received FDA 510(k) clearance on 2009-09-02 under 510(k) number K083724. 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 WIENER LAB. URINE STRIP 10 AND 11?

WIENER LAB. URINE STRIP 10 AND 11 is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Wiener Laboratorios Saic. The 510(k) number is K083724.

When did WIENER LAB. URINE STRIP 10 AND 11 receive FDA 510(k) clearance?

WIENER LAB. URINE STRIP 10 AND 11 received FDA 510(k) clearance on 2009-09-02, under 510(k) number K083724.

Who is the listed applicant for WIENER LAB. URINE STRIP 10 AND 11?

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

What is the FDA product code for WIENER LAB. URINE STRIP 10 AND 11?

The FDA product code for WIENER LAB. URINE STRIP 10 AND 11 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K040703URISTIK 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.

↑