Cleared Traditional

K790702 - ANTISERUM

K790702 is the FDA 510(k) clearance for ANTISERUM by Kent Laboratories, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K790702 · Kent Laboratories, Inc. · Immunology device
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Sep 1979
Decision
145d
Days
Class 2
Risk

K790702 is an FDA 510(k) clearance for the ANTISERUM, HUMAN, IGG H & L CHAIN. 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 September 4, 1979 after a review of 145 days - within the typical 510(k) review window.

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 K790702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1979
Decision Date September 04, 1979
Days to Decision 145 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 104d · This submission: 145d
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 K790702.
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGG
K791403 · Sherwood Medical Co. · Oct 1979
ANTISERUM TO HUMAN IMMUNOGLOBULINS
K791824 · Icl Scientific · Oct 1979
ANTISERUM TO HUMAN IGG
K790704 · Kent Laboratories, Inc. · Apr 1979
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · Kallestad Laboratories, Inc. · Dec 1977
GOAT ANTISERUM IGG NEPHELOMETRIC
K770961 · Kallestad Laboratories, Inc. · Jun 1977