Cleared Traditional

AFT(R) HEP PERFORMANCE EVALUATION PROGRAM (K865019) - FDA 510(k) Clearance

K865019 · Behring Diagnostics, Inc. · Immunology device
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Feb 1987
Decision
49d
Days
-
Risk

K865019 is an FDA 510(k) clearance for the AFT(R) HEP PERFORMANCE EVALUATION PROGRAM.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 49 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K865019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date February 10, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 104d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -