PREDICTOR

Kit, Test, Pregnancy, Hcg, Over The Counter

ORGANON, INC.

The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Predictor.

Pre-market Notification Details

• Device ID: K780240
• 510k Number: K780240
• Device Name: PREDICTOR
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-02-13
• Decision Date: 1978-02-27