Cleared Traditional

K834348 - LEECO T3-QUANT DIAG. KIT

K834348 is the FDA 510(k) clearance for LEECO T3-QUANT DIAG. KIT by Leeco Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K834348 · Leeco Diagnostics, Inc. · Chemistry device
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Feb 1984
Decision
70d
Days
Class 2
Risk

K834348 is an FDA 510(k) clearance for the LEECO T3-QUANT DIAG. KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 70 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K834348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date February 21, 1984
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 93
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K834348.
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SOPHEIA T3 EIA KIT
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ENDAB T3
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K832353 · Corning Medical & Scientific · Aug 1983