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FDA 510(k)

Randox Calcium (Ca)

K-Number: K182042 · 2018-10-23

ApplicantRandox Laboratories, Ltd.
Decision Date2018-10-23
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Randox Calcium (Ca) is a medical device manufactured by Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2018-10-23 under approval number K182042. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Randox Calcium (Ca)?

Randox Calcium (Ca) is a medical device that received FDA 510(k) clearance on 2018-10-23. It is manufactured by Randox Laboratories, Ltd.. The 510(k) number is K182042.

When was Randox Calcium (Ca) approved by the FDA?

Randox Calcium (Ca) received FDA 510(k) clearance on 2018-10-23, under approval number K182042.

What company makes Randox Calcium (Ca)?

Randox Calcium (Ca) is manufactured by Randox Laboratories, Ltd..

What is the FDA product code for Randox Calcium (Ca)?

The FDA product code for Randox Calcium (Ca) is CJY.

Other Devices by Randox Laboratories, Ltd.

K152085Liquid CO2-2 (LCO2-2) K153435Direct HDL Cholesterol (HDL) K162200Randox RX Daytona Plus Magnesium (MG) K230890ISE Electrodes DEN240035ConcizuTrace™ ELISA

Related Devices (Code: CJY)

K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SAS K244042Calcium2Abbott Ireland

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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