MINICLINIC PREGNANCY TEST

Visual, Pregnancy Hcg, Prescription Use

VANGUARD BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Vanguard Biomedical Corp. with the FDA for Miniclinic Pregnancy Test.

Pre-market Notification Details

Device IDK894012
510k NumberK894012
Device Name:MINICLINIC PREGNANCY TEST
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego,  CA  92111
ContactChiu, Ph.d.
CorrespondentChiu, Ph.d.
VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego,  CA  92111
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-06
Decision Date1989-07-25

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