LDP · Class II · 21 CFR 862.3030

FDA Product Code LDP: Colorimetry, Acetaminophen

Leading manufacturers include Diagnostic Chemicals , Ltd., Sekisui Diagnostics P.E.I., Inc. and Stanbio Laboratory.

37
Total
37
Cleared
96d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 88d avg (recent)

FDA 510(k) Cleared Colorimetry, Acetaminophen Devices (Product Code LDP)

37 devices
1–24 of 37
Cleared Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
K261364
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared Feb 18, 2022
Acetaminophen
K202644
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 525d
Cleared Feb 08, 2019
SEKURE Acetaminophen L3K Assay
K180835
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 315d
Cleared Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
K110726
Roche Diagnostics
Chemistry · 282d
Cleared Aug 02, 2010
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200
Siemens Healthcare Diagnostics
Toxicology · 189d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655
Dade Behring, Inc.
Chemistry · 27d
Cleared Feb 28, 2005
TRIAGE TOX DRUG SCREEN
K043242
Biosite Incorporated
Toxicology · 97d
Cleared Jan 07, 2005
ACETAMINOPHEN-SL ASSAY
K042330
Diagnostic Chemicals , Ltd.
Toxicology · 133d
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974
Dade Behring, Inc.
Chemistry · 55d
Cleared Apr 14, 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494
Beckman Coulter, Inc.
Toxicology · 59d
Cleared Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
K991598
Roche Diagnostics Corp.
Toxicology · 73d
Cleared May 12, 1998
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059
Diagnostic Chemicals , Ltd.
Toxicology · 50d
Cleared Mar 03, 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031
Diagnostic Chemicals , Ltd.
Toxicology · 57d
Cleared Sep 23, 1996
ACETAMINOPHEN FLEX REAGENT CARTRIDGE
K963244
Dade Intl., Inc.
Toxicology · 35d
Cleared Jul 08, 1996
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373
Diagnostic Reagents, Inc.
Toxicology · 90d
Cleared Dec 18, 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933
Johnson & Johnson Clinical Diagnostics, Inc.
Toxicology · 52d
Cleared Sep 06, 1995
ACETAMINOPHEN ASSAY
K952949
Diagnostic Chemicals , Ltd.
Toxicology · 72d
Cleared Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094
Abbott Laboratories
Toxicology · 52d
Cleared Jan 11, 1989
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 33d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Apr 17, 1985
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278
Stanbio Laboratory
Toxicology · 16d

About Product Code LDP - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code LDP since 1980, with 37 receiving FDA clearance (average review time: 96 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LDP Product Code

FDA review times for LDP submissions have been consistent, averaging 88 days recently vs 97 days historically.

LDP devices are reviewed by the Toxicology panel. Browse all Toxicology devices →