Cleared Traditional

K810302 - QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM

K810302 is the FDA 510(k) clearance for QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM by Bio-Rad. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810302 · Bio-Rad · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Feb 1981

Decision

20d

Days

Class 1

Risk

K810302 is an FDA 510(k) clearance for the QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on February 25, 1981 after a review of 20 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 Bio-Rad devices

Submission Details

510(k) Number	K810302 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 05, 1981
Decision Date	February 25, 1981
Days to Decision	20 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

68d faster than avg

Panel avg: 88d · This submission: 20d

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 68

Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K810302.

AMERLEX LH RIA KIT (CODE IM2081)

K820753 · Amersham Corp. · Apr 1982

LUTEINIZING HORMONE DIRECT RIA KIT 125/I

K811024 · Immunalysis Corporation · May 1981

LEECO LH-QUANT DIAGNOSTIC KIT

K810662 · Leeco Diagnostics, Inc. · Mar 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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K810302

Bio-Rad

Mchenry, IL · US

Regulatory profile

319 submissions 319 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active