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510(k) Data Aggregation
K Number
K060825Device Name
MULTI-USE ELECTRONIC PREGNANCY TEST
Manufacturer
Date Cleared
2006-06-19
(84 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
MIZUHO USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Multi-Use Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. The test will be marketed for the retail or "over-the-counter" (OTC) market use.
Device Description
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K Number
K043231Device Name
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
Manufacturer
Date Cleared
2005-04-25
(154 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
MIZUHO USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The test will be marketed for the retail or "over-the-counter" (OTC) market use.
Device Description
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K Number
K000844Device Name
ABSOLUTE HCG PREGNANCY TEST
Manufacturer
Date Cleared
2000-06-16
(93 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
MIZUHO USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964002Device Name
NATURALE HCG PREGNANCY TES
Manufacturer
Date Cleared
1996-11-07
(31 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
MIZUHO USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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