FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K020792 |
BAYER DIAGNOSTICS CORP. |
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
07/11/2002 |
K011465 |
BECKMAN COULTER, INC. |
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
06/08/2001 |
K000494 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
04/14/2000 |
K043242 |
BIOSITE INCORPORATED |
TRIAGE TOX DRUG SCREEN |
02/28/2005 |
K061655 |
DADE BEHRING, INC. |
DIMENSION VISTA FLEX REAGENT CARTRIDGES |
07/10/2006 |
K002974 |
DADE BEHRING, INC. |
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
10/11/2000 |
K963244 |
DADE INTL., INC. |
ACETAMINOPHEN FLEX REAGENT CARTRIDGE |
09/23/1996 |
K980031 |
DIAGNOSTIC CHEMICALS LTD. |
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 |
03/03/1998 |
K042330 |
DIAGNOSTIC CHEMICALS LTD. |
ACETAMINOPHEN-SL ASSAY |
01/07/2005 |
K981059 |
DIAGNOSTIC CHEMICALS LTD. |
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. |
05/12/1998 |
K961373 |
DIAGNOSTIC REAGENTS, INC. |
ACETAMINOPHEN SERUM TOX EIA ASSAY |
07/08/1996 |
K081938 |
GENZYME DIAGNOSTICS P.E.I. INC. |
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 |
05/01/2009 |
K110726 |
Roche Diagnostics |
ROCHE ACETAMINOPHEN ASSAY |
12/23/2011 |
K991598 |
ROCHE DIAGNOSTICS CORP. |
COBAS INTEGRA ACETAMINOPHEN |
07/22/1999 |
K013757 |
ROCHE DIAGNOSTICS CORP. |
ROCHE ACETAMINOPHEN |
01/08/2002 |
K202644 |
Sekisui Diagnostics P.E.I. INC. |
Acetaminophen |
02/18/2022 |
K180835 |
Sekisui Diagnostics PEI Inc. |
SEKURE Acetaminophen L3K Assay |
02/08/2019 |
K100200 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
08/02/2010 |