The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Shigella Dysenteriae Group A1 (8-10) Antiserum.
| Device ID | K961535 |
| 510k Number | K961535 |
| Device Name: | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) 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 |