The following data is part of a premarket notification filed by Sero-immuno Diagnostics, Inc. with the FDA for Dirrect Agglutination(dag) Pregnancy Test.
| Device ID | K852286 |
| 510k Number | K852286 |
| Device Name: | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 616 Tucker, GA 30085 |
| Contact | Irving G Kagan |
| Correspondent | Irving G Kagan SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 616 Tucker, GA 30085 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-09 |