HEMAGEN CHAGAS' KIT (EIA METHOD)

Enzyme Linked Immunosorbent Assay, T. Cruzi

HEMAGEN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Chagas' Kit (eia Method).

Pre-market Notification Details

Device IDK930272
510k NumberK930272
Device Name:HEMAGEN CHAGAS' KIT (EIA METHOD)
ClassificationEnzyme Linked Immunosorbent Assay, T. Cruzi
Applicant HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham,  MA  02154
ContactCharles A Willand
CorrespondentCharles A Willand
HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham,  MA  02154
Product CodeMIU  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-19
Decision Date1995-05-19

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