Cleared Traditional

K832164 - COAT-A-COUNT FREE T3 RIA KIT

K832164 is an FDA 510(k) clearance for COAT-A-COUNT FREE T3 RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K832164

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.

CDP Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K832164.
LEECO T3-QUANT DIAG. KIT
K834348 · Leeco Diagnostics, Inc. · Feb 1984
T3 RIA
K833853 · Syncor Intl. Corp. · Feb 1984
ENDAB T3
K834049 · Immunotech Corp. · Jan 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