The following data is part of a premarket notification filed by Investigacion Farmaceutica S.a. De C.v. with the FDA for Proteus Ox-19 Ifa*.
| Device ID | K885110 |
| 510k Number | K885110 |
| Device Name: | PROTEUS OX-19 IFA* |
| Classification | Antigens, Febrile (weil-felix), All Groups |
| Applicant | INVESTIGACION FARMACEUTICA S.A. DE C.V. CALLE 13-E NO. 5 CIVAC JIUTEPEC, MORELOS Mexico, MX |
| Contact | Smithers Hogg. |
| Correspondent | Smithers Hogg. INVESTIGACION FARMACEUTICA S.A. DE C.V. CALLE 13-E NO. 5 CIVAC JIUTEPEC, MORELOS Mexico, MX |
| Product Code | GSZ |
| CFR Regulation Number | 866.3410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-08-15 |