MEDICOUNT DEKA HEMATOLOGY ANALYZER

Counter, Differential Cell

CEA AMERICA CORP.

The following data is part of a premarket notification filed by Cea America Corp. with the FDA for Medicount Deka Hematology Analyzer.

Pre-market Notification Details

Device IDK942525
510k NumberK942525
Device Name:MEDICOUNT DEKA HEMATOLOGY ANALYZER
ClassificationCounter, Differential Cell
Applicant CEA AMERICA CORP. 5300 MEMORIAL DR. #310 Houston,  TX  77007
ContactThomas Burtnett
CorrespondentThomas Burtnett
CEA AMERICA CORP. 5300 MEMORIAL DR. #310 Houston,  TX  77007
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-27
Decision Date1996-06-05

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