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510(k) Data Aggregation
K Number
K983599Device Name
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
Manufacturer
Date Cleared
1998-12-11
(58 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ANDWIN SCIENTIFIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit is utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for Chlamydial diagnostic testing.
Device Description
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K Number
K983428Device Name
SAFETEX CERVICAL SCRAPER (PLASTIC)
Manufacturer
Date Cleared
1998-11-16
(48 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ANDWIN SCIENTIFIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SAFETEX Cervical Spatula (plastic) is used to scrape and remove cytological material from the cervix or vagina.
Device Description
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K Number
K964698Device Name
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
Manufacturer
Date Cleared
1997-03-03
(101 days)
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
ANDWIN SCIENTIFIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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