Search Results
Found 2 results
510(k) Data Aggregation
K Number
K980205Device Name
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
Manufacturer
Date Cleared
1998-02-12
(23 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
SAN DIEGO BIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K974851Device Name
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
Manufacturer
Date Cleared
1998-01-22
(24 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
SAN DIEGO BIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The San Diego Biotech HCG Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. THIS TEST IS INTENDED FOR PROFESSIONAL AND LABORATORY USE ONLY.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1