Cleared Traditional

K790703 - ANTISERUM

K790703 is the FDA 510(k) clearance for ANTISERUM by Kent Laboratories, Inc.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway .

K790703 · Kent Laboratories, Inc. · Immunology device
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Apr 1979
Decision
-
Days
Class 2
Risk

K790703 is an FDA 510(k) clearance for the ANTISERUM, HUMAN, IGA. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Walker, 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 K790703 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 CZP Iga, 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 - CZP Iga, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K790703.
GEMENI IGA ASSAY
K800449 · Electro-Nucleonics Laboratories, Inc. · Mar 1980
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGA
K791401 · Sherwood Medical Co. · Oct 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · Abbott Laboratories · Apr 1979
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · Kallestad Laboratories, Inc. · Dec 1977
IMMOCHEMISTRY SYSTEM
K771603 · Beckman Instruments, Inc. · Sep 1977