The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Albp.
| Device ID | K981457 |
| 510k Number | K981457 |
| Device Name: | ALBP |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | ABBOTT MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Contact | Mark Littlefield |
| Correspondent | Mark Littlefield ABBOTT MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-05-27 |
| Summary: | summary |