Cleared Traditional

K822759 - ABBOTT LABORATORIES PROLACTIN EIA

K822759 is an FDA 510(k) clearance for ABBOTT LABORATORIES PROLACTIN EIA, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K822759 · Abbott Laboratories · Chemistry device

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Oct 1982

Decision

37d

Days

Class 1

Risk

K822759 is an FDA 510(k) clearance for the ABBOTT LABORATORIES PROLACTIN EIA. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 21, 1982 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K822759

510(k) Number	K822759 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1982
Decision Date	October 21, 1982
Days to Decision	37 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

51d faster than avg

Panel avg: 88d · This submission: 37d

Pathway characteristics

Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code	CFT Radioimmunoassay, Prolactin (lactogen)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1625

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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 56

Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K822759.

TANDEM - EPRL

K843804 · Hybritech, Inc. · Nov 1984

PROLACTIN RIABEAD PROLACTIN RADIOIMM

K841118 · Abbott Laboratories · May 1984

COAT-A-COUNT NHS-PROLACTIN KIT AND

K833925 · Diagnostic Products Corp. · Jan 1984

TANDEM PROLACTIN KIT

K821545 · Hybritech, Inc. · Jun 1982

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT

K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982

CENTRIA PROLACTIN TEST SET

K813572 · Ventrex Laboratories, Inc. · Mar 1982

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 K822759

Abbott Laboratories

Abbott Park, IL · US

Regulatory profile

883 submissions 868 cleared

98% clearance rate · Active in Chemistry

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 . Updated monthly.

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