The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Albumin Bcp.
| Device ID | K193001 |
| 510k Number | K193001 |
| Device Name: | Albumin BCP |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | Sentinel CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Contact | Patricia Dupe |
| Correspondent | Patricia Dupe Sentinel CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058056681980 | K193001 | 000 |