Oreia-Tu Thyroid Uptaker Ratio Assay
FDA 510(k) K791172 · Organon, Inc.
510(k) numberK791172
Submission
- Device name
- Oreia-Tu Thyroid Uptaker Ratio Assay
- Applicant
- Organon, Inc.
Mchenry, IL, US - Received
- June 25, 1979
- Decision date
- October 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Oreia-Tu Thyroid Uptaker Ratio Assay cleared by the FDA?
Oreia-Tu Thyroid Uptaker Ratio Assay (K791172) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 127 days after the submission was received.