TOA MEDICAL ELECTRONICS CA-1000

System, Multipurpose For In Vitro Coagulation Studies

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Toa Medical Electronics Ca-1000.

Pre-market Notification Details

Device IDK942096
510k NumberK942096
Device Name:TOA MEDICAL ELECTRONICS CA-1000
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant SYSMEX CORP. 4410 CERRITOS AVE. Los Alamitos,  CA  90720
ContactJeme Wallace
CorrespondentJeme Wallace
SYSMEX CORP. 4410 CERRITOS AVE. Los Alamitos,  CA  90720
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-14
Decision Date1995-03-24

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