Cleared Traditional

K790703 - ANTISERUM, HUMAN, IGA

K790703 is an FDA 510(k) clearance for ANTISERUM, manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K790703

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.

CZP Device Classification - Class 2, Special Controls

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 48
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