Cleared Traditional

K940243 - VENTANA EMA PRIMARY ANDIBODY

K940243 is an FDA 510(k) clearance for VENTANA EMA PRIMARY ANDIBODY, manufactured by Ventana Medical Systems, Inc.. The device is a Class 1 Immunology device with product code DHF cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K940243 · Ventana Medical Systems, Inc. · Immunology device
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Sep 1994
Decision
231d
Days
Class 1
Risk

K940243 is an FDA 510(k) clearance for the VENTANA EMA PRIMARY ANDIBODY. Classified as D/km-1, Antigen, Antiserum, Control (product code DHF), Class I - General Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 231 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5065 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K940243

510(k) Number K940243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1994
Decision Date September 07, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 105d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

DHF Device Classification - Class 1, General Controls

Product Code DHF D/km-1, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5065
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.