SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT

Tubes, Vials, Systems, Serum Separators, Blood Collection

ANDWIN SCIENTIFIC

The following data is part of a premarket notification filed by Andwin Scientific with the FDA for Safetex Combination Blood (alcohol, Ethyl) / Urine Collection And Transport Kit.

Pre-market Notification Details

Device IDK964698
510k NumberK964698
Device Name:SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant ANDWIN SCIENTIFIC 1219 EAST BRIDLETRAIL RD. Draper,  UT  84020 -8523
ContactA. Thomas Doyle
CorrespondentA. Thomas Doyle
ANDWIN SCIENTIFIC 1219 EAST BRIDLETRAIL RD. Draper,  UT  84020 -8523
Product CodeJKA  
Subsequent Product CodeGJE
Subsequent Product CodeLYY
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-22
Decision Date1997-03-03

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