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FDA 510(k)

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

K-Number: K093098 · 2009-12-23

ApplicantArkray, Inc.
Decision Date2009-12-23
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K093098. 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 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM?

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Arkray, Inc.. The 510(k) number is K093098.

When did AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM receive FDA 510(k) clearance?

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM received FDA 510(k) clearance on 2009-12-23, under 510(k) number K093098.

Who is the listed applicant for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM?

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

What is the FDA product code for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM?

The FDA product code for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM is KQO.

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Other records listing Arkray, 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.

K232416AUTION EYE AI-4510 Urine Particle Analysis SystemK193514AUTION MAX AX-4060 Urinalysis SystemK221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceK200788Assure Titanium Blood Glucose Monitoring SystemK160062AUTION ELEVEN Semi-Automated Urinalysis SystemK121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

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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 IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK070929ACON U120 URINE ANALYZER, MODEL U111-101ACON Laboratories, Inc.

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.

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