The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Plasma Transfer Set.
| Device ID | K820447 |
| 510k Number | K820447 |
| Device Name: | ALPHA PLASMA TRANSFER SET |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | ALPHA THERAPEUTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-18 |
| Decision Date | 1982-04-14 |