AXSYM PHENYTOIN ASSAY

Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Phenytoin Assay.

Pre-market Notification Details

Device IDK935375
510k NumberK935375
Device Name:AXSYM PHENYTOIN ASSAY
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park,  IL  60064 -3500
ContactKathy Zeng
CorrespondentKathy Zeng
ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park,  IL  60064 -3500
Product CodeLGR  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-08
Decision Date1994-06-21

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