The following data is part of a premarket notification filed by Investigacion Farmaceutica S.a. De C.v. with the FDA for Salmonella Ifa*.
Device ID | K885114 |
510k Number | K885114 |
Device Name: | SALMONELLA IFA* |
Classification | Tube, Sedimentation Rate |
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 | GHC |
CFR Regulation Number | 864.6700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-12 |
Decision Date | 1989-08-15 |