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FDA 510(k)

URISCREEN

K-Number: K981084 · 1998-10-07

ApplicantDiatech Diagnostics,Inc.
Decision Date1998-10-07
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URISCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Diatech Diagnostics,Inc.. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K981084. 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 URISCREEN?

URISCREEN is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Diatech Diagnostics,Inc.. The 510(k) number is K981084.

When did URISCREEN receive FDA 510(k) clearance?

URISCREEN received FDA 510(k) clearance on 1998-10-07, under 510(k) number K981084.

Who is the listed applicant for URISCREEN?

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

What is the FDA product code for URISCREEN?

The FDA product code for URISCREEN is JXA.

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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)OsmetechK972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON 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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