510(k) K013538

Device: ETHANOL
Applicant: ABBOTT LABORATORIES
510(k) number: K013538
Product code: DML
Decision: Substantially Equivalent (SESE)
Decision date: 2001-12-14
Date received: 2001-10-24
Regulation: 862.3040
Classification name: Nad-nadh, Specific Reagent For Alcohol Enzyme Method
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ALICIA SIMPSON
Address: 1920 Hurd Dr., Ms 8-21 Irving TX US 75038 75038

FDA Registration Numbers#

9610529
2517506
9610126
3006198300
3003795116
2432235

Source Documents#

Other 510(k) Records For Product Code DML #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K993980	SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL	Syva Co.	2000-02-01
K963197	ON.SITE ALCOHOL	Ansys, Inc.	1996-09-19
K953765	AXSYM REA ETHANOL	Abbott Laboratories	1995-09-27
K952839	BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY	Boehringer Mannheim Corp.	1995-08-24
K923337	ON*SITE ALCOHOL	Toxi-Lab, Inc.	1993-01-12
K914777	SIGMA PROCEDURE NO. 333-UV	Sigma Diagnostics, Inc.	1991-12-27
K874382	RAICHEM(TM) ALCOHOL REAGENT	Reagents Applications, Inc.	1988-01-11
K872180	KINETIC 610 ETHANOL	American Monitor Corp.	1987-07-07
K863419	EMDS(TM) ALCOHOL TESTPACKS, #67691/95	Em Diagnostic Systems, Inc.	1986-09-29
K840769	PARAMAX ALCOHOL REAGENT	American Dade	1984-04-13
K840400	EMIT ST SERUM ETHYL ALCOHOL ASSAY	Syva Co.	1984-03-23
K840171	EMIT ST URINE ETHYL ALCOHOL ASSAY	Syva Co.	1984-03-19

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases