B-NEOCEPT
Agglutination Method, Human Chorionic Gonadotropin
ORGANON, INC.
The following data is part of a premarket notification filed by Organon, Inc. with the FDA for B-neocept.
Pre-market Notification Details
| Device ID | K812334 |
| 510k Number | K812334 |
| Device Name: | B-NEOCEPT |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | ORGANON, 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 | 1981-08-18 |
| Decision Date | 1981-09-01 |
Trademark Results [B-NEOCEPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 B-NEOCEPT 73338619 1224733 Dead/Cancelled |
Organon Inc. 1981-11-23 |
 B-NEOCEPT 73338135 1242468 Dead/Cancelled |
Organon Inc. 1981-11-20 |
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