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FDA 510(k)

AUTION JET AJ-4270 URINE ANALYZER

K-Number: K030600 · 2003-07-11

ApplicantInternational Remote Imaging Systems
Decision Date2003-07-11
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTION JET AJ-4270 URINE ANALYZER 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 2003-07-11 under 510(k) number K030600. 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 JET AJ-4270 URINE ANALYZER?

AUTION JET AJ-4270 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is International Remote Imaging Systems. The 510(k) number is K030600.

When did AUTION JET AJ-4270 URINE ANALYZER receive FDA 510(k) clearance?

AUTION JET AJ-4270 URINE ANALYZER received FDA 510(k) clearance on 2003-07-11, under 510(k) number K030600.

Who is the listed applicant for AUTION JET AJ-4270 URINE ANALYZER?

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 JET AJ-4270 URINE ANALYZER?

The FDA product code for AUTION JET AJ-4270 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 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.

K013783AUTION MAX AX-4280 URINALYSIS SYSTEMK945913IRISPEC 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

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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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