FDA 510(k) Applications for Medical Device Product Code "LDP"
(Colorimetry, Acetaminophen)
| 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 |
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