Cleared Traditional

K801123 - TRIIODOTHYRONINE RADIOIMMUN. SYSTEM

K801123 is the FDA 510(k) clearance for TRIIODOTHYRONINE RADIOIMMUN. SYSTEM by Calbiochem-Behring Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K801123 · Calbiochem-Behring Corp. · Chemistry device
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Jun 1980
Decision
28d
Days
Class 2
Risk

K801123 is an FDA 510(k) clearance for the TRIIODOTHYRONINE RADIOIMMUN. SYSTEM. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 28 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K801123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date June 09, 1980
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K801123.
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K800436 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1980
AMERLEX T-3 RIA KIT
K800374 · Amersham Corp. · Mar 1980