ABBOTT PHARAMACOKINETICS SYSTEMS

Medical Computers And Software

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Pharamacokinetics Systems.

Pre-market Notification Details

Device IDK851573
510k NumberK851573
Device Name:ABBOTT PHARAMACOKINETICS SYSTEMS
ClassificationMedical Computers And Software
Applicant ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
ContactMary E Zorc
CorrespondentMary E Zorc
ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
Product CodeLNX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-17
Decision Date1986-01-08

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