The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno-cept D (beta-monoclonal).
| Device ID | K863741 |
| 510k Number | K863741 |
| Device Name: | IMMUNO-CEPT D (BETA-MONOCLONAL) |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-11-13 |