MODIFICATION TO RAICHEM CALCIUM REAGENT

Azo Dye, Calcium

HEMAGEN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Modification To Raichem Calcium Reagent.

Pre-market Notification Details

Device IDK022049
510k NumberK022049
Device Name:MODIFICATION TO RAICHEM CALCIUM REAGENT
ClassificationAzo Dye, Calcium
Applicant HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia,  MD  21045
ContactJose A Montanez
CorrespondentJose A Montanez
HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia,  MD  21045
Product CodeCJY  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-24
Decision Date2002-07-19

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