The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Albumin.
| Device ID | K003327 |
| 510k Number | K003327 |
| Device Name: | ALBUMIN |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2000-12-05 |