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

Enzyme Immunoassay, Valproic Acid

ABBOTT LABORATORIES INC

The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Architect Ivalproic Acid Reagents And Architect Ivalproic Acid Calibrators, Models 1p35, 1p35.

Pre-market Notification Details

Device IDK090358
510k NumberK090358
Device Name:ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
ClassificationEnzyme Immunoassay, Valproic Acid
Applicant ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP6C-2; DEPT 049C Abbott Park,  IL  60064
ContactJudi Wallach
CorrespondentJudi Wallach
ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP6C-2; DEPT 049C Abbott Park,  IL  60064
Product CodeLEG  
CFR Regulation Number862.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-12
Decision Date2009-08-06
Summary:summary

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