QUPID PLUS E.R.

Visual, Pregnancy Hcg, Prescription Use

STANBIO LABORATORY

The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Qupid Plus E.r..

Pre-market Notification Details

Device IDK020378
510k NumberK020378
Device Name:QUPID PLUS E.R.
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne,  TX  78006
ContactKirk Johnson
CorrespondentKirk Johnson
STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne,  TX  78006
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-05
Decision Date2002-06-21
Summary:summary

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