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FDA 510(k)

THE YELLOW IRIS URINALYSIS WORKSTATION

K-Number: K972141 · 1997-08-25

ApplicantIntl. Remote Imaging Systems
Decision Date1997-08-25
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE YELLOW IRIS URINALYSIS WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Remote Imaging Systems. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972141. 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 THE YELLOW IRIS URINALYSIS WORKSTATION?

THE YELLOW IRIS URINALYSIS WORKSTATION is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K972141.

When did THE YELLOW IRIS URINALYSIS WORKSTATION receive FDA 510(k) clearance?

THE YELLOW IRIS URINALYSIS WORKSTATION received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972141.

Who is the listed applicant for THE YELLOW IRIS URINALYSIS WORKSTATION?

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

What is the FDA product code for THE YELLOW IRIS URINALYSIS WORKSTATION?

The FDA product code for THE YELLOW IRIS URINALYSIS WORKSTATION is KQO.

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Other records listing Intl. 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.

K022774IQ 200 SYSTEMK000373939UDX URINE PATHOLOGY SYSTEMK953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYK943463THE YELLOW IRIS

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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 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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