510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Set, Transfer (blood/plasma)

Alpha Therapeutic Corporation

The following data is part of a premarket notification filed by Alpha Therapeutic Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK950044
510k NumberBK950044
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationSet, Transfer (blood/plasma)
Applicant Alpha Therapeutic Corporation 13111 Temple Avenue City Of Industry,  CA  91746
Product CodeKSB  
CFR Regulation Number864.9875 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-09
Decision Date1995-10-18

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