IMMUNOCARD(TM) HCG II TEST KIT

Visual, Pregnancy Hcg, Prescription Use

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard(tm) Hcg Ii Test Kit.

Pre-market Notification Details

Device IDK881709
510k NumberK881709
Device Name:IMMUNOCARD(TM) HCG II TEST KIT
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactR Krutzik
CorrespondentR Krutzik
DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-20
Decision Date1988-07-08

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