The following data is part of a premarket notification filed by Investigacion Farmaceutica S.a. De C.v. with the FDA for Ifa Sensibac Penicillin.
Device ID | K892726 |
510k Number | K892726 |
Device Name: | IFA SENSIBAC PENICILLIN |
Classification | Susceptibility Test Discs, Antimicrobial |
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 | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-14 |
Decision Date | 1989-08-15 |