MINI STRIP/SERUM HCG

Visual, Pregnancy Hcg, Prescription Use

INTERNATIONAL NEWTECH DEVELOPMENT, INC.

The following data is part of a premarket notification filed by International Newtech Development, Inc. with the FDA for Mini Strip/serum Hcg.

Pre-market Notification Details

Device IDK963132
510k NumberK963132
Device Name:MINI STRIP/SERUM HCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c.,  CA V6v 2n8
ContactJesse Zhu
CorrespondentJesse Zhu
INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c.,  CA V6v 2n8
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-12
Decision Date1996-11-18

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