The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Neocept.
Device ID | K811941 |
510k Number | K811941 |
Device Name: | 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 | 1981-07-06 |
Decision Date | 1981-07-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NEOCEPT 73201065 1165989 Dead/Cancelled |
Organon Inc. 1979-01-22 |