Cleared Traditional

K770731 - EAGENT SYSTEM, CORTISOL, ARIA (FDA 510(k) Clearance)

K770731 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Jun 1977
Decision
65d
Days
-
Risk

K770731 is an FDA 510(k) clearance for the EAGENT SYSTEM, CORTISOL, ARIA.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Immunology 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K770731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1977
Decision Date June 24, 1977
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 104d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -