510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843378Substantially Equivalent

Ethyl Alcohol Assay Kit

Diagnostic Chemicals, Ltd. (USA), Canada / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843378 is the FDA 510(k) clearance record for ETHYL ALCOHOL ASSAY KIT, a class II device, cleared for Diagnostic Chemicals, Ltd. (Usa) on under FDA product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet). FDA records list 77 510(k) clearances for Diagnostic Chemicals, Ltd. (Usa), from to . As of , FDA records show no recalls naming K843378.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Regulation
21 CFR 862.3040
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Chemicals, Ltd. (Usa) 4 Newland Crescent, Canada
Third party review
No

Clearances, product code DMT

Trailing 12 months

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

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