K791172Substantially Equivalent

Oreia-Tu Thyroid Uptaker Ratio Assay

Name: K791172 Oreia-Tu Thyroid Uptaker Ratio Assay
Creator: Organon, Inc.
Published: 1979-10-30
License: https://open.fda.gov/license/

Organon LLC, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K791172 is the FDA 510(k) clearance record for OREIA-TU THYROID UPTAKER RATIO ASSAY, cleared for Organon, Inc. on 1979-10-30. FDA records list 42 510(k) clearances for Organon, Inc., from 1977-04-28 to 2026-05-15. As of 2026-09-10, FDA records show no recalls naming K791172.

Clearance record

Decision date: 1979-10-30
Received: 1979-06-25 (127 days to decision)
Review panel: Unknown
Applicant: Organon, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No