FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K093879 |
ACON LABORATORIES, INC. |
MISSION SALIVA ALCOHOL TEST STRIP |
08/06/2010 |
K023184 |
BAYER DIAGNOSTICS CORP. |
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
11/18/2002 |
K972011 |
BEHRING DIAGNOSTICS, INC. |
OPUS ETHANOL |
07/22/1997 |
K121247 |
CHEMATICS, INC. |
ALCO-SCREEN |
03/22/2013 |
K121256 |
CHEMATICS, INC. |
ALCO-SCREEN 02 |
09/12/2012 |
K061792 |
DADE BEHRING, INC. |
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI |
07/18/2006 |
K070853 |
DADE BEHRING, INC. |
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 |
06/13/2007 |
K071811 |
DADE BEHRING, INC. |
ETOH FLEX REAGENT CARTRIDGE (DF22) |
08/24/2007 |
K955633 |
DIAGNOSTIC CHEMICALS LTD. |
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 |
05/24/1996 |
K993920 |
DIAGNOSTIC CHEMICALS LTD. |
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 |
01/18/2000 |
K001286 |
DIAGNOSTIC CHEMICALS LTD. |
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 |
06/20/2000 |
K974002 |
DIAGNOSTIC CHEMICALS LTD. |
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 |
04/01/1998 |
K181553 |
Immunalysis Corporation |
Immunalysis Ethyl Alcohol Enzyme Assay |
10/31/2018 |
K032461 |
Lin-Zhi International, Inc. |
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
10/03/2003 |
K111005 |
MEDICA CORP. |
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL |
11/15/2011 |
K972725 |
POINTE SCIENTIFIC, INC. |
ALCOHOL REAGENT SET |
09/25/1997 |
K092273 |
RANDOX LABORATORIES, LTD. |
RANDOX ETHANOL ASSAY |
11/01/2010 |
K010960 |
SYVA CO., DADE BEHRING, INC. |
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 |
04/26/2001 |
K111206 |
TECO DIAGNOSTICS |
TECO DIAGNOSTICS SALIVA ALCOHOL TEST |
10/04/2011 |