The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for V-trend Qc Urine Chemistry Controls Level, I & Ii.
| Device ID | K861756 |
| 510k Number | K861756 |
| Device Name: | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| 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 | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-07-07 |