AD150, AUTOMATED HEMATOLOGY DILUTOR

Apparatus, Automated Blood Cell Diluting

ABBOTT DIAGNOSTICS

The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Ad150, Automated Hematology Dilutor.

Pre-market Notification Details

Device IDK852373
510k NumberK852373
Device Name:AD150, AUTOMATED HEMATOLOGY DILUTOR
ClassificationApparatus, Automated Blood Cell Diluting
Applicant ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View,  CA  94043
ContactRuth M Becker
CorrespondentRuth M Becker
ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View,  CA  94043
Product CodeGKH  
CFR Regulation Number864.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-04
Decision Date1985-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.