The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Test, Serosonic Albumin.
| Device ID | K760355 |
| 510k Number | K760355 |
| Device Name: | TEST, SEROSONIC ALBUMIN |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-02 |
| Decision Date | 1976-10-05 |