The following data is part of a premarket notification filed by Streck with the FDA for Nrbc-chex For Advia.
| Device ID | K080016 |
| 510k Number | K080016 |
| Device Name: | NRBC-CHEX FOR ADVIA |
| Classification | Control, Red-cell |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Erin Johnson |
| Correspondent | Erin Johnson Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | GJR |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-03 |
| Decision Date | 2008-02-05 |
| Summary: | summary |