Atlas FDA

LEG

35 FDA 510(k) clearances · Product code

60 daysmedian time to decision
148 days90th percentile
35clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Valproic Acid
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3645
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 29 · 2014: 20 · 2016: 25 · 2018: 24 · 2019: 13 · 2022: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358)Abbott Laboratories, Inc.2009-08-06
ONLINE VALPROIC ACID (K060690)Roche Diagnostics Corp.2006-08-08
ADVIA IMS VALPROIC ACID METHOD (K042807)Bayer Healthcare, LLC2005-02-08
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476)Ortho-Clinical Diagnostics, Inc.2004-12-01
ROCHE ONLINE TDM VALPROIC ACID (K032049)Roche Diagnostics Corp.2003-08-22
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870)Beckman Coulter, Inc.2003-07-15
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (K030405)Seradyn2003-04-28
RANDOX VALPROIC ACID (K011649)Randox Laboratories, Ltd.2002-01-15
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (K011947)Syva Co.2001-07-02
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL (K002551)Dade Behring, Inc.2000-10-11
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 (K000005)Diagnostic Products Corp.2000-03-03
DIMENSION(R) VALPROIC (VALP) ACID METHOD (K982880)Dade Behring, Inc.1998-08-25
ACE VALPROIC ACID REAGENT, AED CALIBRATORS (K973581)Schiapparelli Biosystems, Inc.1997-11-12
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS (K972132)Sigma Diagnostics, Inc.1997-07-30
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964442)Bayer Corp.1996-12-18
VALPROIC ACID EIA TEST (K961988)Diagnostic Reagents, Inc.1996-07-16
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT (K961256)Beckman Instruments, Inc.1996-05-15
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID (K953224)Roche Diagnostic Systems, Inc.1995-10-30
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS (K943866)Sigma Diagnostics, Inc.1994-11-10
AXSYM VALPROIC ACID (K941615)Abbott Laboratories1994-08-16
VALPROIC ACID (K936208)Seradyn, Inc.1994-03-11
BIOTRACK VALPROIC ACID TEST CARTRIDGE (K934061)Biotrack, Inc.1993-12-29
CEDIA VALPORIC ACID ASSAY (K930734)Microgenics Corp.1993-09-21
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS (K925003)Roche Diagnostic Systems, Inc.1992-12-03
BECKMAN VALPROIC ACID REAGENT (K922844)Beckman Instruments, Inc.1992-10-26
INNOFLUOR(TM) VALPROIC ACID REAGENT SET (K911688)Intl. Bioclinical, Inc.1991-07-05
MODIFIED OPUS VALPROIC ACID TEST SYSTEM (K901538)Pb Diagnostic Systems, Inc.1990-06-26
VALPROIC ACID (FPIA) KIT (K895569)Tudor Laboratories, Inc.1989-10-03
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS (K891581)Roche Diagnostic Systems, Inc.1989-08-15
EMIT VALPROIC ACID ASSAY (K862652)Syva Co.1986-07-29
EMIT AED VALPROIC ACID ASSAY (K832719)Syva Co.1983-10-04
AMES TDA VALPROIC ACID TEST (K830789)Miles Laboratories, Inc.1983-04-12
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA (K822933)Syva Co.1982-10-27
CYBREX VALPROIC ACID (K803236)Abbott Laboratories1981-01-28
EMIT VALPROIC ACID ASSAY (K801207)Syva Co.1980-06-20

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Every clearance here is in the API, with alerts when new ones post.