Cleared Traditional

K842537 - VON WILLEBRAND FACTOR ANTIGEN SCREEN (FDA 510(k) Clearance)

Class I Hematology device.

K842537 · American Dade · Hematology device
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Oct 1984
Decision
95d
Days
Class 1
Risk

K842537 is an FDA 510(k) clearance for the VON WILLEBRAND FACTOR ANTIGEN SCREEN. Classified as Crystal Violet For Histology (product code ICF), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Dade devices

Submission Details

510(k) Number K842537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date October 01, 1984
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ICF Crystal Violet For Histology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.