Mdi Quik Test Narcotics Drug Screen

FDA 510(k) K853140 · Medical Diagnostics, Ca.

Substantially Equivalent

510(k) numberK853140

Submission

Device name
Mdi Quik Test Narcotics Drug Screen
Applicant
Medical Diagnostics, Ca.
Columbia, MD, US
Received
July 29, 1985
Decision date
March 3, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DNK – Thin Layer Chromatography, Morphine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3640
Specialty
Clinical Toxicology

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K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…DNK · Traditional Nantong Egens Biotech Co., Ltd.07/16/2015SE
K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineDNK · Traditional Guangzhou Wondfo Biotech Co., Ltd.04/07/2015SE
K970579One Step Morphine Card TestDNK · Traditional Teco Diagnostics07/03/1997SE

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Questions and answers

When was Mdi Quik Test Narcotics Drug Screen cleared by the FDA?

Mdi Quik Test Narcotics Drug Screen (K853140) received a 510(k) decision of Substantially Equivalent on March 3, 1986, 217 days after the submission was received.

What is the product code of K853140?

The FDA product code is DNK – Thin Layer Chromatography, Morphine, a Class II (moderate risk) device regulated under 21 CFR 862.3640.