Cleared Traditional

K850140 - CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY (FDA 510(k) Clearance)

K850140 · Corning Medical & Scientific · Chemistry device
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Feb 1985
Decision
23d
Days
-
Risk

K850140 is an FDA 510(k) clearance for the CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY.

Submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K850140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 06, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -