SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT

Spatula, Cervical, Cytological

ANDWIN SCIENTIFIC

The following data is part of a premarket notification filed by Andwin Scientific with the FDA for Safetex Chlamydia Trachomatis Specimen Collection Kit.

Pre-market Notification Details

Device IDK983599
510k NumberK983599
Device Name:SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
ClassificationSpatula, Cervical, Cytological
Applicant ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park,  CA  91303
ContactNatalie Sarraf
CorrespondentNatalie Sarraf
ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park,  CA  91303
Product CodeHHT  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-14
Decision Date1998-12-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.