IMMUNOCARD HCG II-S 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 Hcg Ii-s Test Kit.

Pre-market Notification Details

Device IDK895912
510k NumberK895912
Device Name:IMMUNOCARD HCG II-S TEST KIT
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactSiegfried Krutzik
CorrespondentSiegfried 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 Received1989-10-10
Decision Date1989-12-01

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