The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for V-trend Aso Plus Latex Test.
| Device ID | K853857 |
| 510k Number | K853857 |
| Device Name: | V-TREND ASO PLUS LATEX TEST |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| 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 | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021598 | K853857 | 000 |
| 00816057020133 | K853857 | 000 |
| 00816057020140 | K853857 | 000 |
| 00816057020157 | K853857 | 000 |
| 00816057020164 | K853857 | 000 |
| 00816057020171 | K853857 | 000 |
| 00816057020188 | K853857 | 000 |
| 00816057021178 | K853857 | 000 |
| 00816057021185 | K853857 | 000 |
| 00816057020126 | K853857 | 000 |