510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240035Unknown

ConcizuTrace™ ELISA

Randox Laboratories, Limited, Crumlin, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN240035 is the FDA 510(k) clearance record for ConcizuTrace™ ELISA, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code SES (Non-Factor Replacement Product Test System). FDA's definition for product code SES reads: "A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of...". FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show no recalls naming DEN240035.

Clearance record

Decision date
Received
(325 days to decision)
Product code
SES Non-Factor Replacement Product Test System
Regulation
21 CFR 864.7298
Device class
Class II
Review panel
Hematology
Applicant
Randox Laboratories, Ltd. 55 Diamond Rd., Crumlin, GB
Third party review
No

Clearances, product code SES

Trailing 12 months

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

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