The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Target Cardiac Troponin I Test.
| Device ID | K972094 |
| 510k Number | K972094 |
| Device Name: | TARGET CARDIAC TROPONIN I TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 BLDG. 2, SUITE 6 Tyler, TX 75707 |
| Contact | Charles W Gill |
| Correspondent | Charles W Gill TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 BLDG. 2, SUITE 6 Tyler, TX 75707 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-07-23 |