The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ualb.
| Device ID | K983774 |
| 510k Number | K983774 |
| Device Name: | UALB |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1999-01-28 |
| Summary: | summary |