The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Albumin (bcp).
| Device ID | K863226 |
| 510k Number | K863226 |
| Device Name: | ALBUMIN (BCP) |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1986-09-17 |