Cleared Traditional

K781436 - DELTA TEST ASSAY, HDL CHLORESTEROL (FDA 510(k) Clearance)

K781436 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Oct 1978
Decision
46d
Days
-
Risk

K781436 is an FDA 510(k) clearance for the DELTA TEST ASSAY, HDL CHLORESTEROL.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 46 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 K781436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1978
Decision Date October 03, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -