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FDA 510(k)

YELLOW IRIS TM

K-Number: K830220 · 1983-06-17

ApplicantIntl. Remote Imaging Systems
Decision Date1983-06-17
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

YELLOW IRIS TM 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 1983-06-17 under 510(k) number K830220. 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 YELLOW IRIS TM?

YELLOW IRIS TM is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K830220.

When did YELLOW IRIS TM receive FDA 510(k) clearance?

YELLOW IRIS TM received FDA 510(k) clearance on 1983-06-17, under 510(k) number K830220.

Who is the listed applicant for YELLOW IRIS TM?

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 YELLOW IRIS TM?

The FDA product code for YELLOW IRIS TM is KQO.

Related Clinical Trials

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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 SYSTEMK972141THE YELLOW IRIS URINALYSIS WORKSTATIONK953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY

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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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