The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Salmonella H Z6 Antiserum.
Device ID | K955188 |
510k Number | K955188 |
Device Name: | SAS SALMONELLA H Z6 ANTISERUM |
Classification | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Contact | Harbi Shadfan |
Correspondent | Harbi Shadfan SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Product Code | GNC |
CFR Regulation Number | 866.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-14 |
Decision Date | 1996-02-02 |