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FDA 510(k)

AUTION MAX AX-4280 URINALYSIS SYSTEM

K-Number: K013783 · 2002-01-18

ApplicantInternational Remote Imaging Systems
Decision Date2002-01-18
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTION MAX AX-4280 URINALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Remote Imaging Systems. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013783. 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 AX-4280 URINALYSIS SYSTEM?

AUTION MAX AX-4280 URINALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is International Remote Imaging Systems. The 510(k) number is K013783.

When did AUTION MAX AX-4280 URINALYSIS SYSTEM receive FDA 510(k) clearance?

AUTION MAX AX-4280 URINALYSIS SYSTEM received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013783.

Who is the listed applicant for AUTION MAX AX-4280 URINALYSIS SYSTEM?

The FDA 510(k) record lists International Remote Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTION MAX AX-4280 URINALYSIS SYSTEM?

The FDA product code for AUTION MAX AX-4280 URINALYSIS SYSTEM 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 International Remote Imaging Systems 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.

K030600AUTION JET AJ-4270 URINE ANALYZERK945913IRISPEC URINE CHEMISTRY CONTROL PART A AND B

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 DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, 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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