Cleared Traditional

K853140 - MDI QUIK TEST NARCOTICS DRUG SCREEN
(FDA 510(k) Clearance)

K853140 · Medical Diagnostics, Ca. · Toxicology device

Mar 1986

Decision

217d

Days

Class 2

Risk

K853140 is an FDA 510(k) clearance for the MDI QUIK TEST NARCOTICS DRUG SCREEN. This device is classified as a Thin Layer Chromatography, Morphine (Class II - Special Controls, product code DNK).

Submitted by Medical Diagnostics, Ca. (Columbia, US). The FDA issued a Cleared decision on March 3, 1986, 217 days after receiving the submission on July 29, 1985.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.

Submission Details

510(k) Number	K853140 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1985
Decision Date	March 03, 1986
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—