Cleared Traditional

K832164 - COAT-A-COUNT FREE T3 RIA KIT

K832164 is the FDA 510(k) clearance for COAT-A-COUNT FREE T3 RIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K832164 · Diagnostic Products Corp. · Chemistry device
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Oct 1983
Decision
114d
Days
Class 2
Risk

K832164 is an FDA 510(k) clearance for the COAT-A-COUNT FREE T3 RIA KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Walker, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K832164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date October 27, 1983
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
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 78
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K832164.
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
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353 · Corning Medical & Scientific · Aug 1983
AMERLEX FREE T-3 RIA KIT
K830980 · Amersham Corp. · May 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808 · Leeco Diagnostics, Inc. · Apr 1983