The following data is part of a premarket notification filed by Technology Management & Marketing, Inc. with the FDA for Gonostat.
| Device ID | K883486 |
| 510k Number | K883486 |
| Device Name: | GONOSTAT |
| Classification | Dna-reagents, Neisseria |
| Applicant | TECHNOLOGY MANAGEMENT & MARKETING, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius TECHNOLOGY MANAGEMENT & MARKETING, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1989-08-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GONOSTAT 75070615 2122246 Dead/Cancelled |
Sierra Diagnostics, Inc. 1996-03-11 |
![]() GONOSTAT 73685745 1490780 Dead/Cancelled |
TECHNOLOGY MANAGEMENT & MARKETING, INC. 1987-09-22 |