Cleared Traditional

K810852 - FOLLICLE STIMULATING HORMONE ANTISERUM

K810852 is the FDA 510(k) clearance for FOLLICLE STIMULATING HORMONE ANTISERUM by Pcl-Ria, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K810852 · Pcl-Ria, Inc. · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1981

Decision

Days

Class 1

Risk

K810852 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE ANTISERUM. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981 after a review of 9 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 Pcl-Ria, Inc. devices

Submission Details

510(k) Number	K810852 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1981
Decision Date	April 08, 1981
Days to Decision	9 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

79d faster than avg

Panel avg: 88d · This submission: 9d

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 53

Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K810852.

AMERLEX ESH KIT

K820754 · Amersham Corp. · Apr 1982

FOLLICLE STIMULATING HORMONE KIT

K820358 · Pcl-Ria, Inc. · Mar 1982

FOLLICLE STIMULATING HORMONE DIRECT RIA

K811905 · Immunalysis Corporation · Jul 1981

LEECO FSH-QUANT DIAGNOSTIC KIT

K810663 · Leeco Diagnostics, Inc. · Mar 1981

HTSH RIABEAD DIAGNOSTIC KIT

K810381 · Abbott Laboratories · Feb 1981

FOLLICE STIMULATING HORMONE-RADIOIMM. KT

K803279 · Immuno Nuclear Corp. · Jan 1981

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 K810852

Pcl-Ria, Inc.

Mchenry, IL · US

Regulatory profile

29 submissions 29 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