The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for V-trend Strep A Test.
| Device ID | K880483 |
| 510k Number | K880483 |
| Device Name: | V-TREND STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| 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 | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-04-12 |