Product code LDP
- Device name
- Colorimetry, Acetaminophen
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3030
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 |
| K110726 | ROCHE ACETAMINOPHEN ASSAY | Roche Diagnostics | 2011-12-23 |
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | 2010-08-02 |
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009-05-01 |
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | 2006-07-10 |
| K043242 | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | 2005-02-28 |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | 2005-01-07 |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 |
| K013757 | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | 2002-01-08 |
| K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | Beckman Coulter, Inc. | 2001-06-08 |
| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | 2000-10-11 |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | 2000-04-14 |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | 1999-07-22 |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | 1998-03-03 |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-23 |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1996-07-08 |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-12-18 |
| K952949 | ACETAMINOPHEN ASSAY | Diagnostic Chemicals , Ltd. | 1995-09-06 |
| K953094 | AXSYM ACETAMINOPHEN | Abbott Laboratories | 1995-08-24 |
| K931257 | ACETASITE | Gds Diagnostics | 1993-07-08 |
| K897118 | SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM | Medisense, Inc. | 1990-05-10 |
| K885097 | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 | Diagnostic Chemicals, Ltd. (Usa) | 1989-01-11 |
| K882719 | EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 | Em Diagnostic Systems, Inc. | 1988-08-08 |
| K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | Gds Technology, LLC | 1988-05-27 |
| K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 | Stanbio Laboratory | 1985-04-17 |
| K844962 | EMIT QST ACETAMINOPHEN ASSAY | Syva Co. | 1985-01-18 |
| K842548 | ACA ACETAMINOPHEN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-08-16 |
| K840941 | TDX ACETAMINOPHEN | Abbott Laboratories | 1984-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654164 | Atellica CH Acetaminophen (AcetC) | Siemens Healthcare Diagnostics Inc. | 2025-10-15 |
| 00628063401314 | Alinity c Acetaminophen | SEKISUI DIAGNOSTICS, LLC | 2023-05-08 |
| 07613336120934 | ONLINE TDM Acetaminophen Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00628063401215 | Acetaminophen L3K Assay | SEKISUI DIAGNOSTICS, LLC | 2019-10-02 |
| 00628063401185 | Acetaminophen Assay | SEKISUI DIAGNOSTICS, LLC | 2019-10-02 |
| 30014613337867 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337904 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 00630414595894 | Atellica CH Acet | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00884883001176 | DRI Acetaminophen Serum Tox Calibrators | Microgenics Corporation | 2016-09-24 |
| 00884883001169 | DRI Acetaminophen Serum Tox Assay | Microgenics Corporation | 2016-09-24 |
| 00842768023330 | Emit® tox™ Acetaminophen Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015014 | Dimension Vista® Flex® reagent cartridge ACTM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414498942 | ADVIA® Chemistry ACET Acetaminophen Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001550 | Syva® Emit® tox™ Acetaminophen Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005787 | Dimension® Flex® reagent cartridge ACTM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630981205 | Acetaminophen | Roche Diagnostics GmbH | 2016-09-23 |
| 00657498000427 | Acetaminophen Liquicolor® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 00899722002757 | Alere Triage® | Alere San Diego, Inc. | 2016-09-21 |
| 04015630935031 | ONLINE TDM Acetaminophen Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630946372 | Acetaminophen | Roche Diagnostics GmbH | 2016-09-20 |
| 00628063400027 | ACETAMINOPHEN L3K | SEKISUI DIAGNOSTICS, LLC | 2016-09-20 |
| 00893038002135 | Alere Triage® | Alere San Diego, Inc. | 2016-09-19 |
| 00628063400034 | ACETAMINOPHEN L3K | SEKISUI DIAGNOSTICS, LLC | 2016-09-16 |
| 00380740003661 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 05055273208139 | ACE | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 15099590229962 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750008339 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |