Cleared Traditional

ALLO-TYPE HUMAN IMMUNOGLOBULIN- (K841114) - FDA 510(k) Clearance

Class I Immunology device.

K841114 · Genetic Testing Institute · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Genetic Testing Institute devices

Submission Details

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
13d faster than avg
Panel avg: 104d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.