Cleared Traditional

OREIA-TU THYROID UPTAKER RATIO ASSAY (K791172) - FDA 510(k) Clearance

K791172 · Organon, Inc. · Chemistry device
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Oct 1979
Decision
127d
Days
-
Risk

K791172 is an FDA 510(k) clearance for the OREIA-TU THYROID UPTAKER RATIO ASSAY.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K791172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date October 30, 1979
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -