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510(k) Data Aggregation
K Number
K053236Device Name
DAVID PREGNANCY TEST (MIDSTREAM)
Manufacturer
Date Cleared
2006-07-18
(242 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
RUNBIO BIOTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
Device Description
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
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