The following data is part of a premarket notification filed by Alpha Therapeutic Corporation with the FDA for Container, Empty, For The Collection '& Processing Of Blood/blood Components.
Device ID | BK870004 |
510k Number | BK870004 |
Device Name: | Container, Empty, For The Collection '& Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles, CA 90032 |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-02 |
Decision Date | 1987-03-11 |