The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Sensi-tex.
| Device ID | K790267 |
| 510k Number | K790267 |
| Device Name: | SENSI-TEX |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-06 |
| Decision Date | 1979-03-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENSI-TEX 74612192 not registered Dead/Abandoned |
OAK RUBBER COMPANY, THE 1994-12-19 |
![]() SENSI-TEX 73221984 1175666 Dead/Cancelled |
Hoffmann-La Roche Inc. 1979-07-02 |
![]() SENSI-TEX 72438827 0999996 Live/Registered |
OAK RUBBER COMPANY, THE 1972-10-19 |