Cleared Traditional

K841734 - TAGO FIFFU-GEN

K841734 is the FDA 510(k) clearance for TAGO FIFFU-GEN by Tago, Inc.. It is a Class 1 Immunology device (product code LKL) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841734 · Tago, Inc. · Immunology device
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Jun 1984
Decision
36d
Days
Class 1
Risk

K841734 is an FDA 510(k) clearance for the TAGO FIFFU-GEN, OROSOMUCOID. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Tago, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tago, Inc. devices

Submission Details

510(k) Number K841734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1984
Decision Date June 01, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
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.

Regulatory Peers - LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (LKL) and FDA review panel - the closest regulatory comparables to K841734.
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
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K884217 · Technicon Instruments Corp. · Nov 1988
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · Unipath , Ltd. · Oct 1987
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · Kent Laboratories, Inc. · Jul 1983