510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162200Substantially Equivalent

Randox RX Daytona Plus Magnesium (MG)

Randox Laboratories, Limited, Crumlin, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162200 is the FDA 510(k) clearance record for Randox RX Daytona Plus Magnesium (MG), a class I device, cleared for Randox Laboratories, Ltd. on under FDA product code JGJ (Photometric Method, Magnesium). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show one recall naming K162200.

Clearance record

Decision date
Received
(266 days to decision)
Product code
JGJ Photometric Method, Magnesium
Regulation
21 CFR 862.1495
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Randox Laboratories, Ltd. 55 Diamond Rd., Crumlin, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JGJ

Trailing 12 months

FDA records hold no clearances under product code JGJ in the trailing twelve months.

FDA records show no clearances under product code JGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JGJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260