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FDA 510(k)

URITEST 50 AND URITEST 500 URINE ANALYZER

K-Number: K091472 · 2010-04-27

ApplicantArj Medical, Inc.
Decision Date2010-04-27
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEST 50 AND URITEST 500 URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Arj Medical, Inc.. It received FDA 510(k) clearance on 2010-04-27 under 510(k) number K091472. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEST 50 AND URITEST 500 URINE ANALYZER?

URITEST 50 AND URITEST 500 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2010-04-27. The listed applicant is Arj Medical, Inc.. The 510(k) number is K091472.

When did URITEST 50 AND URITEST 500 URINE ANALYZER receive FDA 510(k) clearance?

URITEST 50 AND URITEST 500 URINE ANALYZER received FDA 510(k) clearance on 2010-04-27, under 510(k) number K091472.

Who is the listed applicant for URITEST 50 AND URITEST 500 URINE ANALYZER?

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

What is the FDA product code for URITEST 50 AND URITEST 500 URINE ANALYZER?

The FDA product code for URITEST 50 AND URITEST 500 URINE ANALYZER is KQO.

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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Other records listing Arj Medical, 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.

K052719URITEST 10 URINALYSIS REAGENT STRIPSK052708PYLO-PLUS

Related Devices (Code: KQO)

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.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.K070929ACON U120 URINE ANALYZER, MODEL U111-101ACON Laboratories, 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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