Cleared Traditional

K791836 - QUANTIMUNE HFSH RIA

K791836 is the FDA 510(k) clearance for QUANTIMUNE HFSH RIA by Bio-Rad. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K791836 · Bio-Rad · Chemistry device

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Oct 1979

Decision

17d

Days

Class 1

Risk

K791836 is an FDA 510(k) clearance for the QUANTIMUNE HFSH RIA. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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	K791836 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1979
Decision Date	October 01, 1979
Days to Decision	17 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

71d faster than avg

Panel avg: 88d · This submission: 17d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1300

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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 44

Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K791836.

LEECO FSH-QUANT DIAGNOSTIC KIT

K810663 · Leeco Diagnostics, Inc. · Mar 1981

HTSH RIABEAD DIAGNOSTIC KIT

K810381 · Abbott Laboratories · Feb 1981

CENTRIA FSH RIA

K792233 · Union Carbide Corp. · Jan 1980

RIA SYSTEM FOR HUMAN F-S HORMONE

K780870 · Calbiochem-Behring Corp. · Jun 1978

FOLLICLE-STIMULATING HORMONE

K771756 · Nichols Institute Diagnostics · Oct 1977

RADIOASSAY KIT, IM.72 FSH

K760373 · Amersham Corp. · Nov 1976

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 K791836

Bio-Rad

Mchenry, IL · US

Regulatory profile

319 submissions 319 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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

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