The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Shigella Dysenteriae Type 9 Antiserum.
Device ID | K961559 |
510k Number | K961559 |
Device Name: | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM |
Classification | Antisera, All Types, Shigella Spp. |
Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Contact | Martin P O'connor |
Correspondent | Martin P O'connor SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
Product Code | GNB |
CFR Regulation Number | 866.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-22 |
Decision Date | 1996-05-20 |