IMMUNOCARD STREP A TEST

Antisera, All Groups, Streptococcus Spp.

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard Strep A Test.

Pre-market Notification Details

Device IDK896109
510k NumberK896109
Device Name:IMMUNOCARD STREP A TEST
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactJulie Whiteside
CorrespondentJulie Whiteside
DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-23
Decision Date1989-11-29

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