The following data is part of a premarket notification filed by Sero-immuno Diagnostics, Inc. with the FDA for Beta-hcg Hemagglutination Test.
| Device ID | K842181 |
| 510k Number | K842181 |
| Device Name: | BETA-HCG HEMAGGLUTINATION TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | SERO-IMMUNO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-01 |
| Decision Date | 1984-08-22 |