ClearanceBrief
Panels › Clinical Toxicology › Product code LEG · Class 2

Enzyme Immunoassay, Valproic Acid

Regulation 862.3645

0510(k)s in 12 months (35 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in LEG

Company510(k)sRecalls
Syva Co.50
Ortho-Clinical Diagnostics, Inc.13
Abbott Laboratories30
Bayer Healthcare, LLC (Diagnostics Division)03
Roche Diagnostic Systems, Inc.30
Roche Diagnostics Corp.21
Beckman Instruments, Inc.20
Dade Behring, Inc.20
Seradyn20
Sigma Diagnostics, Inc.20
DateFirm and productCodeLinked 510(k)
Dec 11, 2018Ortho-Clinical Diagnostics
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used
Terminated		 LEGK042476
Feb 8, 2012Ortho-Clinical Diagnostics
VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. For in vit
Terminated		 LEGK042476
Jun 9, 2007Roche Diagnostics Corp.
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
Terminated		 LEGK060690
Jan 17, 2007Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio
Terminated		 LEGK990346
Jan 17, 2007Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correct
Terminated		 LEGK990346
Jan 17, 2007Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio
Terminated		 LEGK990346
Jun 4, 2005Ortho-Clinical Diagnostics
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 146
Terminated		 LEGK042476

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