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FDA 510(k)

MULTIPLE (IZON DBS & URINE COLLECTION KIT)

K-Number: K950257 · 1995-04-14

ApplicantIzon Business Products, Inc.
Decision Date1995-04-14
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MULTIPLE (IZON DBS & URINE COLLECTION KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Izon Business Products, Inc.. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K950257. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE (IZON DBS & URINE COLLECTION KIT)?

MULTIPLE (IZON DBS & URINE COLLECTION KIT) is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Izon Business Products, Inc.. The 510(k) number is K950257.

When did MULTIPLE (IZON DBS & URINE COLLECTION KIT) receive FDA 510(k) clearance?

MULTIPLE (IZON DBS & URINE COLLECTION KIT) received FDA 510(k) clearance on 1995-04-14, under 510(k) number K950257.

Who is the listed applicant for MULTIPLE (IZON DBS & URINE COLLECTION KIT)?

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

What is the FDA product code for MULTIPLE (IZON DBS & URINE COLLECTION KIT)?

The FDA product code for MULTIPLE (IZON DBS & URINE COLLECTION KIT) is JXA.

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

Other records listing Izon Business Products, 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.

K010328MULTIPLE (IZON DNA BLOOD COLLECTION KIT)K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)K950246MULTIPLE (IZON URINE COLLECTION KIT)

Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, Inc.

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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