510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853140Substantially Equivalent

Mdi Quik Test Narcotics Drug Screen

Medical Diagnostics, Ca., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853140 is the FDA 510(k) clearance record for MDI QUIK TEST NARCOTICS DRUG SCREEN, a class II device, cleared for Medical Diagnostics, Ca. on under FDA product code DNK (Thin Layer Chromatography, Morphine). FDA records list 4 510(k) clearances for Medical Diagnostics, Ca., from to . As of , FDA records show no recalls naming K853140.

Clearance record

Decision date
Received
(217 days to decision)
Product code
DNK Thin Layer Chromatography, Morphine
Regulation
21 CFR 862.3640
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Medical Diagnostics, Ca. 9062 Rte. 108, Columbia MD
Third party review
No

Clearances, product code DNK

Trailing 12 months

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

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