Enzyme Immunoassay, Valproic Acid

FDA product code LEG · 35 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3645
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-06-20 – 2009-08-06

LEG 2009-08-06

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

Applicant Abbott Laboratories, Inc.

K number K090358

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LEG 2006-08-08

ONLINE VALPROIC ACID

Applicant Roche Diagnostics Corp.

K number K060690

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LEG 2005-02-08

ADVIA IMS VALPROIC ACID METHOD

Applicant Bayer Healthcare, LLC

K number K042807

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LEG 2004-12-01

VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042476

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LEG 2003-08-22

ROCHE ONLINE TDM VALPROIC ACID

Applicant Roche Diagnostics Corp.

K number K032049

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LEG 2003-07-15

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

Applicant Beckman Coulter, Inc.

K number K031870

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LEG 2003-04-28

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075

Applicant Seradyn

K number K030405

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LEG 2002-01-15

RANDOX VALPROIC ACID

Applicant Randox Laboratories, Ltd.

K number K011649

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LEG 2001-07-02

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

Applicant Syva Co.

K number K011947

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LEG 2000-10-11

EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

Applicant Dade Behring, Inc.

K number K002551

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LEG 2000-03-03

IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

Applicant Diagnostic Products Corp.

K number K000005

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LEG 1998-08-25

DIMENSION(R) VALPROIC (VALP) ACID METHOD

Applicant Dade Behring, Inc.

K number K982880

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LEG 1997-11-12

ACE VALPROIC ACID REAGENT, AED CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K973581

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LEG 1997-07-30

SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS

Applicant Sigma Diagnostics, Inc.

K number K972132

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LEG 1996-12-18

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K964442

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LEG 1996-07-16

VALPROIC ACID EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K961988

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LEG 1996-05-15

SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT

Applicant Beckman Instruments, Inc.

K number K961256

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LEG 1995-10-30

COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID

Applicant Roche Diagnostic Systems, Inc.

K number K953224

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LEG 1994-11-10

VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS

Applicant Sigma Diagnostics, Inc.

K number K943866

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LEG 1994-08-16

AXSYM VALPROIC ACID

Applicant Abbott Laboratories

K number K941615

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LEG 1994-03-11

VALPROIC ACID

Applicant Seradyn, Inc.

K number K936208

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LEG 1993-12-29

BIOTRACK VALPROIC ACID TEST CARTRIDGE

Applicant Biotrack, Inc.

K number K934061

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LEG 1993-09-21

CEDIA VALPORIC ACID ASSAY

Applicant Microgenics Corp.

K number K930734

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LEG 1992-12-03

COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS

Applicant Roche Diagnostic Systems, Inc.

K number K925003

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LEG 1992-10-26

BECKMAN VALPROIC ACID REAGENT

Applicant Beckman Instruments, Inc.

K number K922844

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LEG 1991-07-05

INNOFLUOR(TM) VALPROIC ACID REAGENT SET

Applicant Intl. Bioclinical, Inc.

K number K911688

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LEG 1990-06-26

MODIFIED OPUS VALPROIC ACID TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K901538

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LEG 1989-10-03

VALPROIC ACID (FPIA) KIT

Applicant Tudor Laboratories, Inc.

K number K895569

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LEG 1989-08-15

COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS

Applicant Roche Diagnostic Systems, Inc.

K number K891581

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LEG 1986-07-29

EMIT VALPROIC ACID ASSAY

Applicant Syva Co.

K number K862652

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LEG 1983-10-04

EMIT AED VALPROIC ACID ASSAY

Applicant Syva Co.

K number K832719

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LEG 1983-04-12

AMES TDA VALPROIC ACID TEST

Applicant Miles Laboratories, Inc.

K number K830789

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LEG 1982-10-27

SYVA ADVANCE EMIT AED VALPROIC ACID ASSA

Applicant Syva Co.

K number K822933

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LEG 1981-01-28

CYBREX VALPROIC ACID

Applicant Abbott Laboratories

K number K803236

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LEG 1980-06-20

EMIT VALPROIC ACID ASSAY

Applicant Syva Co.

K number K801207

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