Cleared Traditional

K823201 - HUMAN PLACENTAL LACTOGEN KIT

K823201 is the FDA 510(k) clearance for HUMAN PLACENTAL LACTOGEN KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JMF) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K823201 · Diagnostic Products Corp. · Chemistry device

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Nov 1982

Decision

34d

Days

Class 2

Risk

K823201 is an FDA 510(k) clearance for the HUMAN PLACENTAL LACTOGEN KIT. Classified as Radioimmunoassay, Human Placental Lactogen (product code JMF), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1585 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number	K823201 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 26, 1982
Decision Date	November 29, 1982
Days to Decision	34 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

54d faster than avg

Panel avg: 88d · This submission: 34d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JMF Radioimmunoassay, Human Placental Lactogen
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1585

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JMF Radioimmunoassay, Human Placental Lactogen

All 7

Devices cleared under the same product code (JMF) and FDA review panel - the closest regulatory comparables to K823201.

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)

K944933 · Diagnostic Products Corp. · Mar 1995

AMERLEX HUMAN PLACENTAL LACTOGEN

K840588 · Amersham Corp. · Apr 1984

IMMOPHASE TM HPL RADIOIMMUNOASSAY

K823292 · Corning Medical & Scientific · Dec 1982

NATAL-TEC HPL

K811370 · Armkel, LLC · May 1981

CENTRIA HPL RIA

K791854 · Union Carbide Corp. · Oct 1979

PROLACTIN RIA DIAG. KIT

K771656 · Abbott Laboratories · Sep 1977

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 K823201

Diagnostic Products Corp.

Mchenry, IL · US

Regulatory profile

321 submissions 321 cleared

100% clearance rate · Active in Chemistry

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