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510(k) Data Aggregation
K Number
K112315Device Name
HOME PREGNANCY TEST
Manufacturer
Date Cleared
2012-04-23
(256 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The y.b.t. Pregnancy Test is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy.
Device Description
The test is available in two formats: strip and cassette.Both of them are intended for prescription use. Both of them have the same memebrane format, reagents and flow characteristics. Devices are packaged one device per pouch with 1 devices per kit.
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