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FDA 510(k)

IRIS URINE STAIN

K-Number: K821503 · 1982-06-03

ApplicantIntl. Remote Imaging Systems
Decision Date1982-06-03
Product CodeICF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IRIS URINE STAIN 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 1982-06-03 under 510(k) number K821503. The device is classified under product code ICF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS URINE STAIN?

IRIS URINE STAIN is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K821503.

When did IRIS URINE STAIN receive FDA 510(k) clearance?

IRIS URINE STAIN received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821503.

Who is the listed applicant for IRIS URINE STAIN?

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 IRIS URINE STAIN?

The FDA product code for IRIS URINE STAIN is ICF.

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 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: ICF)

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.

K864531TISSUE GRAM STAINSigma Diagnostics, Inc.K842537VON WILLEBRAND FACTOR ANTIGEN SCREENAmerican DadeK842730GENTIAN VIOLETE K Ind., Inc.K792495VOLU-SOL URINARY SEDIMENT STAINVolu Sol Medical Industries

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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