Cleared Traditional

K833853 - T3 RIA

K833853 is an FDA 510(k) clearance for T3 RIA, manufactured by Syncor Intl. Corp.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K833853 · Syncor Intl. Corp. · Chemistry device
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Feb 1984
Decision
92d
Days
Class 2
Risk

K833853 is an FDA 510(k) clearance for the T3 RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Syncor Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 92 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 Syncor Intl. Corp. devices

FDA 510(k) Submission Details - K833853

510(k) Number K833853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1983
Decision Date February 04, 1984
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 100
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K833853.
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
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SOPHEIA T3 EIA KIT
K840050 · Diagnostic Products Corp. · Mar 1984
LEECO T3-QUANT DIAG. KIT
K834348 · Leeco Diagnostics, Inc. · Feb 1984
ENDAB T3
K834049 · Immunotech Corp. · Jan 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