LDP · Class II · 21 CFR 862.3030

FDA Product Code LDP: Colorimetry, Acetaminophen

Leading manufacturers include Beckman Coulter, Inc., Dade Behring, Inc. and Roche Diagnostics Corp..

36
Total
36
Cleared
97d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years

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

36 devices
1–24 of 36
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 Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655
Dade Behring, Inc.
Chemistry · 27d
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 Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094
Abbott Laboratories
Toxicology · 52d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Jan 18, 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962
Syva Co.
Toxicology · 25d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared May 11, 1984
TDX ACETAMINOPHEN
K840941
Abbott Laboratories
Toxicology · 67d
Cleared Aug 24, 1982
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313
Sigma Chemical Co.
Chemistry · 21d
Cleared May 28, 1982
EMIT-TOX ACETAMINOPHEN ASSAY
K821379
Syva Co.
Toxicology · 18d

About Product Code LDP - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code LDP since 1980, with 36 receiving FDA clearance (average review time: 97 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.