The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for V-trend Kit Staph Latex Test.
| Device ID | K855220 |
| 510k Number | K855220 |
| Device Name: | V-TREND KIT STAPH LATEX TEST |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | TEXAS IMMUNOLOGY, INC. P.O. BOX 164 Selman City, TX 75689 |
| Contact | Charles W Gill |
| Correspondent | Charles W Gill TEXAS IMMUNOLOGY, INC. P.O. BOX 164 Selman City, TX 75689 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021581 | K855220 | 000 |
| 00816057020119 | K855220 | 000 |
| 00816057020102 | K855220 | 000 |
| 00816057020096 | K855220 | 000 |
| 00816057020089 | K855220 | 000 |
| 00816057020072 | K855220 | 000 |
| 00816057020065 | K855220 | 000 |
| 20885380020237 | K855220 | 000 |