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510(k) Data Aggregation
K Number
K110433Device Name
CLEARBLUE EASY PREGNANCY TEST
Manufacturer
Date Cleared
2011-05-12
(86 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
SPD DEVELOPMENT COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Clearblue® Plus Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period (5 days before the missed period).
Device Description
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