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FDA 510(k)

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2

K-Number: K043267 · 2005-02-10

ApplicantRandox Laboratories, Ltd.
Decision Date2005-02-10
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2005-02-10 under 510(k) number K043267. The device is classified under product code CEJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2?

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 is a medical device that received FDA 510(k) clearance on 2005-02-10. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K043267.

When did POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 receive FDA 510(k) clearance?

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 received FDA 510(k) clearance on 2005-02-10, under 510(k) number K043267.

Who is the listed applicant for POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2?

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

What is the FDA product code for POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2?

The FDA product code for POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 is CEJ.

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Related Devices (Code: CEJ)

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.

K943026POTASSIUM QVETPrisma SystemsK904033REFLOTRON POTASSIUM TEST TABSBoehringer Mannheim Corp.K902574POTASSIUM REAGENT SETTech-Co, Inc.K883585TECHNICON ASSIST POTASSIUMTechnicon Instruments Corp.K883586TECHNICON RA-100 SYSTEM POTASSIUMTechnicon Instruments Corp.K881440IQ POTASSIUMBd Becton Dickinson Vacutainer Systems Preanalytic

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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