The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Target Microalbuminuria Test.
| Device ID | K912246 |
| 510k Number | K912246 |
| Device Name: | TARGET MICROALBUMINURIA TEST |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 Tyler, TX 75707 |
| Contact | Charles W Gill |
| Correspondent | Charles W Gill TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 Tyler, TX 75707 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-07-19 |