Cleared Traditional

K834586 - LEECO E2 QUANT DIAG. TEST KIT

K834586 is an FDA 510(k) clearance for LEECO E2 QUANT DIAG. TEST KIT, manufactured by Leeco Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K834586 · Leeco Diagnostics, Inc. · Chemistry device

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Mar 1984

Decision

71d

Days

Class 1

Risk

K834586 is an FDA 510(k) clearance for the LEECO E2 QUANT DIAG. TEST KIT. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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.

FDA 510(k) Submission Details - K834586

510(k) Number	K834586 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 1983
Decision Date	March 09, 1984
Days to Decision	71 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

18d faster than avg

Panel avg: 89d · This submission: 71d

Pathway characteristics

Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

Product Code	CHP Radioimmunoassay, Estradiol
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1260

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 - CHP Radioimmunoassay, Estradiol

All 49

Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K834586.

ESTRADIOL DIRECT RIA KIT

K851540 · Biotecx Laboratories, Inc. · Jun 1985

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

K841947 · Sorin Biomedica, Fiat, USA, Inc. · Jun 1984

COAT-A-COUNT ESTRADIOL KIT

K840051 · Diagnostic Products Corp. · Mar 1984

ESTRADIOL KIT BY RIA

K820329 · Immuchem Corp. · Mar 1982

ESTRIOL RADIOIMMUNOASSAY TEST KIT

K810695 · Serono Laboratories, Inc. · Mar 1981

17B ESTRADIOL

K810204 · Pantex, Div. Bio-Analysis, Inc. · Mar 1981

FDA 510(k) Resources - Chemistry

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

Manufacturer of K834586

Leeco Diagnostics, Inc.

Walker, MI · US

Regulatory profile

49 submissions 49 cleared

100% clearance rate · Active in Chemistry

View all devices by Leeco Diagnostics, Inc. →

About This 510(k) Record

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 . FDA decision: March 9, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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