Cleared Traditional

K864611 - IMMUNO-SURE (FDA 510(k) Clearance)

K864611 · Coulter Electronics, Inc. · Hematology device
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Feb 1987
Decision
72d
Days
-
Risk

K864611 is an FDA 510(k) clearance for the IMMUNO-SURE.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Hematology 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K864611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date February 04, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 113d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -