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FDA 510(k)

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

K-Number: K110846 · 2011-09-30

ApplicantRandox Laboratories Limited
Decision Date2011-09-30
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K110846. 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 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2?

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Randox Laboratories Limited. The 510(k) number is K110846.

When did RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 receive FDA 510(k) clearance?

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 received FDA 510(k) clearance on 2011-09-30, under 510(k) number K110846.

Who is the listed applicant for RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2?

The FDA product code for RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 is JJW.

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Other records listing Randox Laboratories Limited as applicant

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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 CompleteStreckK103387MISSION 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.K052242ADVIA CHEMISTRY MICROALBUMIN CONTROLSBayer Healthcare, LLC

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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