Cleared Traditional

CENTRIA T3 UPTAKE TEST SET (K791050) - FDA 510(k) Clearance

K791050 · Ventrex Laboratories, Inc. · Toxicology device
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Jun 1979
Decision
9d
Days
-
Risk

K791050 is an FDA 510(k) clearance for the CENTRIA T3 UPTAKE TEST SET.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Toxicology 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.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K791050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1979
Decision Date June 15, 1979
Days to Decision 9 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 87d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -