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 Neocept.

Pre-market Notification Details

Device IDK811941
510k NumberK811941
Device Name:NEOCEPT
ClassificationAgglutination Method, Human Chorionic Gonadotropin
Applicant ORGANON, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHJ  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-06
Decision Date1981-07-27

Trademark Results [NEOCEPT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEOCEPT
NEOCEPT
73201065 1165989 Dead/Cancelled
Organon Inc.
1979-01-22

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