The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for H-flu B Elisa Test.
| Device ID | K831525 |
| 510k Number | K831525 |
| Device Name: | H-FLU B ELISA TEST |
| Classification | Antisera, All Types, H. Influenza |
| Applicant | SERAGEN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRP |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-09-29 |