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FDA 510(k)

IRI SPEC URINALYSIS CONTROL

K-Number: K832713 · 1983-12-22

ApplicantIntl. Remote Imaging Systems
Decision Date1983-12-22
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRI SPEC URINALYSIS CONTROL 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 1983-12-22 under 510(k) number K832713. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRI SPEC URINALYSIS CONTROL?

IRI SPEC URINALYSIS CONTROL is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K832713.

When did IRI SPEC URINALYSIS CONTROL receive FDA 510(k) clearance?

IRI SPEC URINALYSIS CONTROL received FDA 510(k) clearance on 1983-12-22, under 510(k) number K832713.

Who is the listed applicant for IRI SPEC URINALYSIS CONTROL?

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 IRI SPEC URINALYSIS CONTROL?

The FDA product code for IRI SPEC URINALYSIS CONTROL is JJW.

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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: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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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