The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Albumin Procedure Bcp.
| Device ID | K832632 |
| 510k Number | K832632 |
| Device Name: | ALBUMIN PROCEDURE BCP |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-04 |
| Decision Date | 1983-09-12 |