The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Terumo Imugard.
| Device ID | K790105 |
| 510k Number | K790105 |
| Device Name: | TERUMO IMUGARD |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-16 |
| Decision Date | 1979-05-24 |