510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K024339Substantially Equivalent

Cozart Eia Opiates Oral Fluid Kit

Cozart Bioscience, Ltd., Oxfordshire Ox14 4ru, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K024339 is the FDA 510(k) clearance record for COZART EIA OPIATES ORAL FLUID KIT, a class I device, cleared for Cozart Bioscience , Ltd. on under FDA product code DIG (Cholinesterase Test Paper). FDA records list 6 510(k) clearances for Cozart Bioscience , Ltd., from to . As of , FDA records show no recalls naming K024339.

Clearance record

Decision date
Received
(101 days to decision)
Product code
DIG Cholinesterase Test Paper
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Cozart Bioscience , Ltd. 45 Milton Park, Oxfordshire Ox14 4ru, GB
510(k) summary
Statement
Third party review
No

Clearances, product code DIG

Trailing 12 months

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

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