Cleared Traditional

K842537 - VON WILLEBRAND FACTOR ANTIGEN SCREEN

K842537 is an FDA 510(k) clearance for VON WILLEBRAND FACTOR ANTIGEN SCREEN, manufactured by American Dade. The device is a Class 1 Hematology device with product code ICF cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K842537

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

ICF Device Classification - Class 1, General Controls

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.