On*Site Alcohol

Q: When was On*Site Alcohol cleared by the FDA?

On*Site Alcohol (K923337) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 208 days after the submission was received.

Q: What is the product code of K923337?

The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.

FDA 510(k) K923337 · Toxi-Lab, Inc.

Substantially Equivalent

510(k) numberK923337

Submission

Device name: On*Site Alcohol
Applicant: Toxi-Lab, Inc.
Irvine, CA, US
Received: June 18, 1992
Decision date: January 12, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.3040
Specialty: Clinical Toxicology

Other 510(k)s with product code DML

510(k)	Device	Applicant	Decision
K013538	EthanolDML · Traditional	Abbott Laboratories	12/14/2001SE
K993980	Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional	Syva Co.	02/01/2000SE
K963197	On.Site AlcoholDML · Traditional	Ansys, Inc.	09/19/1996SE
K953765	Axsym Rea EthanolDML · Traditional	Abbott Laboratories	09/27/1995SE
K952839	Boehringer Mannheim Ethyl Alcohol AssayDML · Traditional	Boehringer Mannheim Corp.	08/24/1995SE
K914777	Sigma Procedure No. 333-UVDML · Traditional	Sigma Diagnostics, Inc.	12/27/1991SE
K874382	Raichem(Tm) Alcohol ReagentDML · Traditional	Reagents Applications, Inc.	01/11/1988SE
K872180	Kinetic 610 EthanolDML · Traditional	American Monitor Corp.	07/07/1987SE
K863419	Emds(Tm) Alcohol Testpacks, #67691/95DML · Traditional	Em Diagnostic Systems, Inc.	09/29/1986SE
K840769	Paramax Alcohol ReagentDML · Traditional	American Dade	04/13/1984SE

More from American Dade

510(k)	Device	Decision
K932209	Toxi*Lab Ltd Opiate SystemLAI · Traditional	09/24/1993SE
K903223	On-Site AlcoholDOJ · Traditional	03/13/1991SE
K901694	Spec(Tm) Extraction CartridgeDKE · Traditional	06/01/1990SE
K900626	Alpha Urine SampleDIF · Traditional	03/06/1990SE

Questions and answers

When was On*Site Alcohol cleared by the FDA?

On*Site Alcohol (K923337) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 208 days after the submission was received.

What is the product code of K923337?

The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.