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 .
Device ID | BK950044 |
510k Number | BK950044 |
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 |
Classification | Set, Transfer (blood/plasma) |
Applicant | Alpha Therapeutic Corporation 13111 Temple Avenue City Of Industry, CA 91746 |
Product Code | KSB |
CFR Regulation Number | 864.9875 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-09 |
Decision Date | 1995-10-18 |