Cleared Traditional

K792350 - CENTRIA LH RIA

K792350 is an FDA 510(k) clearance for CENTRIA LH RIA, manufactured by Union Carbide Corp.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K792350 · Union Carbide Corp. · Chemistry device
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Jan 1980
Decision
58d
Days
Class 1
Risk

K792350 is an FDA 510(k) clearance for the CENTRIA LH RIA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980 after a review of 58 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K792350

510(k) Number K792350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date January 16, 1980
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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 77
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K792350.
LUTENIZING HORMONES
K810754 · Pcl-Ria, Inc. · Mar 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278 · Immuno Nuclear Corp. · Jan 1981
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp. · Sep 1979
RIA KIT, LH
K781685 · Amersham Corp. · Oct 1978
125-I LABELED HUMAN LUTEINIZING HORMONE
K780576 · Pcl-Ria, Inc. · May 1978