Cleared Traditional

K834218 - DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -

K834218 is the FDA 510(k) clearance for DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - by Tago, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K834218 · Tago, Inc. · Immunology device
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May 1984
Decision
155d
Days
Class 1
Risk

K834218 is an FDA 510(k) clearance for the DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Tago, Inc. (Walker, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 155 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 Tago, Inc. devices

Submission Details

510(k) Number K834218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date May 11, 1984
Days to Decision 155 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 104d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.