The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Target Myoglobin Test.
| Device ID | K963680 |
| 510k Number | K963680 |
| Device Name: | TARGET MYOGLOBIN TEST |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 BLDG. 2, SUITE 6 Tyler, TX 75707 |
| Contact | Chrales W Gill |
| Correspondent | Chrales W Gill TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 BLDG. 2, SUITE 6 Tyler, TX 75707 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-02-06 |