K961533 is an FDA 510(k) clearance for the SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM. This device is classified as a Antisera, All Types, Shigella Spp. (Class II - Special Controls, product code GNB).
Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 20, 1996, 28 days after receiving the submission on April 22, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3660.
| 510(k) Number | K961533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1996 |
| Decision Date | May 20, 1996 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GNB — Antisera, All Types, Shigella Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3660 |