K831525 is an FDA 510(k) clearance for the H-FLU B ELISA TEST. This device is classified as a Antisera, All Types, H. Influenza (Class II - Special Controls, product code GRP).
Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 140 days after receiving the submission on May 12, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K831525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1983 |
| Decision Date | September 29, 1983 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GRP — Antisera, All Types, H. Influenza |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |