Cleared Traditional

K841114 - ALLO-TYPE HUMAN IMMUNOGLOBULIN-

K841114 is an FDA 510(k) clearance for ALLO-TYPE HUMAN IMMUNOGLOBULIN-, manufactured by Genetic Testing Institute. The device is a Class 1 Immunology device with product code DGX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K841114 · Genetic Testing Institute · Immunology device
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Jun 1984
Decision
91d
Days
Class 1
Risk

K841114 is an FDA 510(k) clearance for the ALLO-TYPE HUMAN IMMUNOGLOBULIN-. Classified as Ng1m(a), Antigen, Antiserum, Control (product code DGX), Class I - General Controls.

Submitted by Genetic Testing Institute (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 91 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K841114

510(k) Number K841114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1984
Decision Date June 14, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 105d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

DGX Device Classification - Class 1, General Controls

Product Code DGX Ng1m(a), 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.