LEG · Class II · 21 CFR 862.3645

FDA Product Code LEG: Enzyme Immunoassay, Valproic Acid

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Roche Diagnostics Corp..

35
Total
35
Cleared
80d
Avg days
1980
Since

FDA 510(k) Cleared Enzyme Immunoassay, Valproic Acid Devices (Product Code LEG)

35 devices
1–24 of 35
Cleared Aug 08, 2006
ONLINE VALPROIC ACID
K060690
Roche Diagnostics Corp.
Toxicology · 146d
Cleared Feb 08, 2005
ADVIA IMS VALPROIC ACID METHOD
K042807
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476
Ortho-Clinical Diagnostics, Inc.
Chemistry · 79d
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870
Beckman Coulter, Inc.
Toxicology · 28d
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947
Syva Co.
Toxicology · 11d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
K002551
Dade Behring, Inc.
Chemistry · 55d
Cleared Mar 03, 2000
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
K000005
Diagnostic Products Corp.
Toxicology · 60d
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880
Dade Behring, Inc.
Toxicology · 11d
Cleared Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
K972132
Sigma Diagnostics, Inc.
Toxicology · 54d
Cleared Dec 18, 1996
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964442
Bayer Corp.
Chemistry · 42d
Cleared Jul 16, 1996
VALPROIC ACID EIA TEST
K961988
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared May 15, 1996
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
K961256
Beckman Instruments, Inc.
Toxicology · 44d
Cleared Oct 30, 1995
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
K953224
Roche Diagnostic Systems, Inc.
Toxicology · 139d
Cleared Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866
Sigma Diagnostics, Inc.
Chemistry · 94d
Cleared Aug 16, 1994
AXSYM VALPROIC ACID
K941615
Abbott Laboratories
Toxicology · 134d
Cleared Sep 21, 1993
CEDIA VALPORIC ACID ASSAY
K930734
Microgenics Corp.
Toxicology · 222d
Cleared Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Oct 26, 1992
BECKMAN VALPROIC ACID REAGENT
K922844
Beckman Instruments, Inc.
Toxicology · 136d
Cleared Jun 26, 1990
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538
Pb Diagnostic Systems, Inc.
Toxicology · 85d
Cleared Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581
Roche Diagnostic Systems, Inc.
Toxicology · 148d
Cleared Jul 29, 1986
EMIT VALPROIC ACID ASSAY
K862652
Syva Co.
Toxicology · 18d
Cleared Oct 04, 1983
EMIT AED VALPROIC ACID ASSAY
K832719
Syva Co.
Toxicology · 53d

About Product Code LEG - Regulatory Context