Cleared Traditional

K834049 - ENDAB T3

K834049 is the FDA 510(k) clearance for ENDAB T3 by Immunotech Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K834049 · Immunotech Corp. · Chemistry device

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Jan 1984

Decision

68d

Days

Class 2

Risk

K834049 is an FDA 510(k) clearance for the ENDAB T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Immunotech Corp. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - the FDA in vitro diagnostics and chemistry 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 Immunotech Corp. devices

Submission Details

510(k) Number	K834049 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 23, 1983
Decision Date	January 30, 1984
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

20d faster than avg

Panel avg: 88d · This submission: 68d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CDP Radioimmunoassay, Total Triiodothyronine
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1710

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 91

Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K834049.

FREE T3 SOLID PHASE RADIOIMMUNOASSAY

K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984

SOPHEIA T3 EIA KIT

K840050 · Diagnostic Products Corp. · Mar 1984

LEECO T3-QUANT DIAG. KIT

K834348 · Leeco Diagnostics, Inc. · Feb 1984

COAT-A-COUNT FREE T3 RIA KIT

K832164 · Diagnostic Products Corp. · Oct 1983

CORNING'S MAGIC T3(125I) RADIOIMMUNO-

K832353 · Corning Medical & Scientific · Aug 1983

AMERLEX FREE T-3 RIA KIT

K830980 · Amersham Corp. · May 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K834049

Immunotech Corp.

Mchenry, IL · US

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Chemistry

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