AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Fluorometer, For Clinical Use

TOSOH MEDICS, INC.

The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia Nexia-automated Enzyme Immunoassay System.

Pre-market Notification Details

Device IDK971103
510k NumberK971103
Device Name:AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
ClassificationFluorometer, For Clinical Use
Applicant TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City,  CA  94404
ContactLori Robinson
CorrespondentLori Robinson
TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City,  CA  94404
Product CodeKHO  
CFR Regulation Number862.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-26
Decision Date1997-06-27

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