AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Fluorometer, For Clinical Use

TOSOH CORP.

The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Aia-600 Automated Enzyme Immunoassay System.

Pre-market Notification Details

Device IDK901674
510k NumberK901674
Device Name:AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
ClassificationFluorometer, For Clinical Use
Applicant TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactHoward M Holstein
CorrespondentHoward M Holstein
TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeKHO  
CFR Regulation Number862.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-10
Decision Date1990-05-02

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