PROCLINIC ONE STEP 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 Proclinic One Step Pregnancy Test.

Pre-market Notification Details

Device IDK914253
510k NumberK914253
Device Name:PROCLINIC ONE STEP PREGNANCY TEST
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego,  CA  92111
ContactJohn Chiu
CorrespondentJohn Chiu
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 Received1991-09-23
Decision Date1991-10-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066000274 K914253 000
00722066000229 K914253 000

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