The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Plastic Plasma Bottle.
| Device ID | K810897 |
| 510k Number | K810897 |
| Device Name: | ALPHA PLASTIC PLASMA BOTTLE |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | ALPHA THERAPEUTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-03 |
| Decision Date | 1981-09-23 |