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FDA 510(k)

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

K-Number: K043268 · 2005-02-15

ApplicantRandox Laboratories, Ltd.
Decision Date2005-02-15
Product CodeCEI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM TEST KIT AND ELETROLYTE 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 2005-02-15 under 510(k) number K043268. The device is classified under product code CEI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2?

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K043268.

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

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 received FDA 510(k) clearance on 2005-02-15, under 510(k) number K043268.

Who is the listed applicant for SODIUM TEST KIT AND ELETROLYTE 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 SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2?

The FDA product code for SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 is CEI.

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Other records listing Randox Laboratories, Ltd. as applicant

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Related Devices (Code: CEI)

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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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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