Cleared Traditional

FOLLICLE STIMULATING HORMONE (HFSH) (K871317) - FDA 510(k) Clearance

Class I Chemistry device.

K871317 · Immuchem Corp. · Chemistry device
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May 1987
Decision
48d
Days
Class 1
Risk

K871317 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE (HFSH). Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on May 20, 1987 after a review of 48 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 Immuchem Corp. devices

Submission Details

510(k) Number K871317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1987
Decision Date May 20, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 13
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K871317.
COAT-A-COUNT (TM) FSH IRMA
K893976 · Diagnostic Products Corp. · Aug 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · Bio-Rad · Jul 1983
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · Abbott Laboratories · Feb 1981
QUANTIMUNE HFSH RIA
K791836 · Bio-Rad · Oct 1979