The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for V-trend Qc Tdm Control Serum 1,2,3..
| Device ID | K862817 |
| 510k Number | K862817 |
| Device Name: | V-TREND QC TDM CONTROL SERUM 1,2,3. |
| Classification | Drug Mixture Control Materials |
| 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 | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-24 |
| Decision Date | 1986-08-19 |