Saliva Alcohol Test

FDA 510(k) K894001 · Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

Substantially Equivalent

510(k) numberK894001

Submission

Device name
Saliva Alcohol Test
Applicant
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
Horsham, PA, US
Received
June 5, 1989
Decision date
April 5, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3040
Specialty
Clinical Toxicology

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K121247Alco-ScreenDIC · Traditional Chematics, Inc.03/22/2013SE
K121256Alco-Screen 02DIC · Traditional Chematics, Inc.09/12/2012SE
K111005Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional Medica Corp.11/15/2011SE
K111206Teco Diagnostics Saliva Alcohol TestDIC · Traditional Teco Diagnostics10/04/2011SE
K092273Randox Ethanol AssayDIC · Traditional Randox Laboratories, Ltd.11/01/2010SE
K093879Mission Saliva Alcohol Test StripDIC · Traditional ACON Laboratories, Inc.08/06/2010SE
K071811Etoh Flex Reagent Cartridge (DF22)DIC · Traditional Dade Behring, Inc.08/24/2007SE
K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022DIC · Traditional Dade Behring, Inc.06/13/2007SE

More from Dade Behring, Inc.

510(k)DeviceDecision
K911692Enzymatics, Inc., Total Cholesterol TestCHH · Traditional 08/16/1991SE
K903235Statlab A-350 Saliva Alcohol TestDIC · Traditional 10/12/1990SE

Questions and answers

When was Saliva Alcohol Test cleared by the FDA?

Saliva Alcohol Test (K894001) received a 510(k) decision of Substantially Equivalent on April 5, 1990, 304 days after the submission was received.

What is the product code of K894001?

The FDA product code is DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.