510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011393Substantially Equivalent

Randox Phenytoin

Randox Laboratories, Limited, Crumlin, Co. Antrim, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011393 is the FDA 510(k) clearance record for RANDOX PHENYTOIN, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code DIP (Enzyme Immunoassay, Diphenylhydantoin). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show 2 recalls naming K011393.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DIP Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Randox Laboratories, Ltd. 55 Diamond Rd., Crumlin, Co. Antrim, IE
510(k) summary
Statement
Third party review
No

Clearances, product code DIP

Trailing 12 months

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

FDA records show no clearances under product code DIP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIP, 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