Cleared Traditional

K792063 - FOLLICLE STIMULATING HORMONE (FSH) KIT

K792063 is an FDA 510(k) clearance for FOLLICLE STIMULATING HORMONE (FSH) KIT, manufactured by Cis Radiopharmaceuticals, Inc.. The device is a Class 1 Immunology device with product code CGJ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K792063 · Cis Radiopharmaceuticals, Inc. · Immunology device
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Nov 1979
Decision
36d
Days
Class 1
Risk

K792063 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE (FSH) KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1300 - the FDA immunology device 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 Cis Radiopharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K792063

510(k) Number K792063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date November 20, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 105d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

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 70
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K792063.
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · Abbott Laboratories · Feb 1981
FOLLICE STIMULATING HORMONE-RADIOIMM. KT
K803279 · Immuno Nuclear Corp. · Jan 1981
CENTRIA FSH RIA
K792233 · Union Carbide Corp. · Jan 1980
QUANTIMUNE HFSH RIA
K791836 · Bio-Rad · Oct 1979
RIA SYSTEM FOR HUMAN F-S HORMONE
K780870 · Calbiochem-Behring Corp. · Jun 1978
FOLLICLE-STIMULATING HORMONE
K771756 · Nichols Institute Diagnostics · Oct 1977