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FDA 510(k)

Randox RX Daytona Plus Magnesium (MG)

K-Number: K162200 · 2017-04-28

ApplicantRandox Laboratories, Ltd.
Decision Date2017-04-28
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Randox RX Daytona Plus Magnesium (MG) 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 2017-04-28 under 510(k) number K162200. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Randox RX Daytona Plus Magnesium (MG)?

Randox RX Daytona Plus Magnesium (MG) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K162200.

When did Randox RX Daytona Plus Magnesium (MG) receive FDA 510(k) clearance?

Randox RX Daytona Plus Magnesium (MG) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162200.

Who is the listed applicant for Randox RX Daytona Plus Magnesium (MG)?

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 Randox RX Daytona Plus Magnesium (MG)?

The FDA product code for Randox RX Daytona Plus Magnesium (MG) is JGJ.

Other records listing Randox Laboratories, Ltd. 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.

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Related Devices (Code: JGJ)

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.

K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.

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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