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FDA 510(k)

URINE SCREENING DEVICE

K-Number: K972676 · 1998-02-23

ApplicantCombact Diagnostic Systems , Ltd.
Decision Date1998-02-23
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URINE SCREENING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Combact Diagnostic Systems , Ltd.. It received FDA 510(k) clearance on 1998-02-23 under 510(k) number K972676. 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 URINE SCREENING DEVICE?

URINE SCREENING DEVICE is a medical device that received FDA 510(k) clearance on 1998-02-23. The listed applicant is Combact Diagnostic Systems , Ltd.. The 510(k) number is K972676.

When did URINE SCREENING DEVICE receive FDA 510(k) clearance?

URINE SCREENING DEVICE received FDA 510(k) clearance on 1998-02-23, under 510(k) number K972676.

Who is the listed applicant for URINE SCREENING DEVICE?

The FDA 510(k) record lists Combact Diagnostic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE SCREENING DEVICE?

The FDA product code for URINE SCREENING DEVICE 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.

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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)OsmetechK981084URISCREENDiatech Diagnostics,Inc.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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