Cleared Traditional

K802883 - T3-SQUIBB RIA KIT

K802883 is an FDA 510(k) clearance for T3-SQUIBB RIA KIT, manufactured by E. R. Squibb & Sons, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802883 · E. R. Squibb & Sons, Inc. · Chemistry device
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Dec 1980
Decision
32d
Days
Class 2
Risk

K802883 is an FDA 510(k) clearance for the T3-SQUIBB RIA KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by E. R. Squibb & Sons, Inc. (New Brunswick, US). The FDA issued a Cleared decision on December 19, 1980 after a review of 32 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 E. R. Squibb & Sons, Inc. devices

FDA 510(k) Submission Details - K802883

510(k) Number K802883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 19, 1980
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K802883.
T3 RIA KIT
K810211 · E. R. Squibb & Sons, Inc. · Feb 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · Abbott Laboratories · Jan 1981
1-125 LABELED TRIIODOTHYRONINE(T3)
K803180 · Pcl-Ria, Inc. · Jan 1981
T3 RADIOIMMUNOASSAY KIT
K802470 · American Diagnostic Corp. · Nov 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · Calbiochem-Behring Corp. · Jun 1980
SPAC T3 RIA TEST KIT
K801125 · Mallinckrodt Critical Care · Jun 1980