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FDA 510(k)

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

K-Number: K162275 · 2017-04-21

ApplicantRandox Laboratories Limited
Decision Date2017-04-21
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Randox RX Daytona Plus Alkaline Phosphatase (ALP) is a medical device manufactured by Randox Laboratories Limited. It received FDA 510(k) clearance on 2017-04-21 under approval number K162275. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

Randox RX Daytona Plus Alkaline Phosphatase (ALP) is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Randox Laboratories Limited. The 510(k) number is K162275.

When was Randox RX Daytona Plus Alkaline Phosphatase (ALP) approved by the FDA?

Randox RX Daytona Plus Alkaline Phosphatase (ALP) received FDA 510(k) clearance on 2017-04-21, under approval number K162275.

What company makes Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

Randox RX Daytona Plus Alkaline Phosphatase (ALP) is manufactured by Randox Laboratories Limited.

What is the FDA product code for Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

The FDA product code for Randox RX Daytona Plus Alkaline Phosphatase (ALP) is CJE.

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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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