Hemacon-Doa(Tm) Drugs of Abuse Whole Blood Control

FDA 510(k) K901276 · Diagnostic Products Corp.

Substantially Equivalent

510(k) numberK901276

Submission

Device name
Hemacon-Doa(Tm) Drugs of Abuse Whole Blood Control
Applicant
Diagnostic Products Corp.
Los Angeles, CA, US
Received
March 19, 1990
Decision date
April 26, 1990
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
K790805Drug Abuse DipsticksDIT · Traditional Technical Resources, Inc.06/06/1979SE

More from Technical Resources, Inc.

510(k)DeviceDecision
K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated 12/22/2006SE
K063045Immulite 2000, Immulite 2500 VancomycinLEH · Traditional 12/05/2006SE
K060929Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special 04/28/2006SE
K053533Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional 02/03/2006SE
K034055Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special 01/21/2004SE
K033234Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional 12/12/2003SE
K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special 10/10/2003SE
K023152Immulite 2000 Allergen-Specific IgeDHB · Abbreviated 12/17/2002SE
K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional 12/09/2002SE
K022603Immulite 1000 Automated Immunoassay AnalyzerCEW · Special 08/21/2002SE

Questions and answers

When was Hemacon-Doa(Tm) Drugs of Abuse Whole Blood Control cleared by the FDA?

Hemacon-Doa(Tm) Drugs of Abuse Whole Blood Control (K901276) received a 510(k) decision of Substantially Equivalent on April 26, 1990, 38 days after the submission was received.

What is the product code of K901276?

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