Cleared Traditional

K790704 - ANTISERUM TO HUMAN IGG

K790704 is the FDA 510(k) clearance for ANTISERUM TO HUMAN IGG by Kent Laboratories, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway .

K790704 · Kent Laboratories, Inc. · Immunology device

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Apr 1979

Decision

Days

Class 2

Risk

K790704 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN IGG. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1979.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kent Laboratories, Inc. devices

Submission Details

510(k) Number	K790704 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received	April 12, 1979
Decision Date	April 12, 1979
Days to Decision	-
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DEW Igg, Antigen, Antiserum, Control
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5510

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 Immunology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 54

Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K790704.

LANCER L-INA ANTI-IGG

K791403 · Sherwood Medical Co. · Oct 1979

ANTISERUM TO HUMAN IMMUNOGLOBULINS

K791824 · Icl Scientific · Oct 1979

ANTISERUM, HUMAN, IGG H & L CHAIN

K790702 · Kent Laboratories, Inc. · Sep 1979

IMMUNOGLOBULIN G NEPHEL. ASSAY

K772252 · Kallestad Laboratories, Inc. · Dec 1977

GOAT ANTISERUM IGG NEPHELOMETRIC

K770961 · Kallestad Laboratories, Inc. · Jun 1977

DASP TM ANTI-RABBIT

K770597 · Organon, Inc. · Apr 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 K790704

Kent Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

40 submissions 37 cleared

93% clearance rate · Active in Immunology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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