Drug Abuse Dipsticks

FDA 510(k) K790805 · Technical Resources, Inc.

Substantially Equivalent

510(k) numberK790805

Submission

Device name
Drug Abuse Dipsticks
Applicant
Technical Resources, Inc.
Mchenry, IL, US
Received
April 25, 1979
Decision date
June 6, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DIT – Thin Layer Chromatography, Amphetamine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3100
Specialty
Clinical Toxicology

Other 510(k)s with product code DIT

510(k)DeviceApplicantDecision
K972577Quick Screen One Step Amphetamine TestDIT · Traditional Phamatech08/20/1997SE
K910525Microline Screen for MethamphetamineDIT · Traditional Drug Screening Systems, Inc.04/05/1991SE
K901276Hemacon-Doa(Tm) Drugs of Abuse Whole Blood ControlDIT · Traditional Diagnostic Products Corp.04/26/1990SE

More from Diagnostic Products Corp.

510(k)DeviceDecision
K810572Blade, Handle, Scalpel Forceps, SurgeryGES · Traditional 03/20/1981SE
K792473Therapette, Model No MH-100GZJ · Traditional 12/20/1979SE

Questions and answers

When was Drug Abuse Dipsticks cleared by the FDA?

Drug Abuse Dipsticks (K790805) received a 510(k) decision of Substantially Equivalent on June 6, 1979, 42 days after the submission was received.

What is the product code of K790805?

The FDA product code is DIT – Thin Layer Chromatography, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.