Cleared Traditional

K803278 - LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT

K803278 is the FDA 510(k) clearance for LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT by Immuno Nuclear Corp.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K803278 · Immuno Nuclear Corp. · Chemistry device
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Jan 1981
Decision
23d
Days
Class 1
Risk

K803278 is an FDA 510(k) clearance for the LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Immuno Nuclear Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 Immuno Nuclear Corp. devices

Submission Details

510(k) Number K803278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1980
Decision Date January 21, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K803278.
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · Immunalysis Corporation · May 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · Leeco Diagnostics, Inc. · Mar 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981
CENTRIA LH RIA
K792350 · Union Carbide Corp. · Jan 1980
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp. · Sep 1979
RIA KIT, LH
K781685 · Amersham Corp. · Oct 1978