Cleared Traditional

K834218 - DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -

K834218 is an FDA 510(k) clearance for DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -, manufactured by Tago, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K834218

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
50d slower than avg
Panel avg: 105d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

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.