MINICLINIC OVULATION PREDICTION TEST

Radioimmunoassay, Luteinizing Hormone

VANGUARD BIOMEDICAL CORP.

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

Pre-market Notification Details

Device IDK910351
510k NumberK910351
Device Name:MINICLINIC OVULATION PREDICTION TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
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 CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-15
Decision Date1991-03-21

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