Cleared Traditional

K790709 - ANTISERUM TO RABBIT IMMUNOGLOBULIN

K790709 is an FDA 510(k) clearance for ANTISERUM TO RABBIT IMMUNOGLOBULIN, manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with product code DFZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K790709 · Kent Laboratories, Inc. · Immunology device
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Aug 1979
Decision
126d
Days
Class 2
Risk

K790709 is an FDA 510(k) clearance for the ANTISERUM TO RABBIT IMMUNOGLOBULIN. Classified as Igg (gamma Chain Specific), Antigen, Antiserum, Control (product code DFZ), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 126 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

FDA 510(k) Submission Details - K790709

510(k) Number K790709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1979
Decision Date August 16, 1979
Days to Decision 126 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
21d slower than avg
Panel avg: 105d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFZ Device Classification - Class 2, Special Controls

Product Code DFZ Igg (gamma Chain Specific), 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 - DFZ Igg (gamma Chain Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DFZ) and FDA review panel - the closest regulatory comparables to K790709.
BOEHRINGER MANNHEIM IGG ASSAY
K955906 · Boehringer Mannheim Corp. · Feb 1996
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
K940422 · The Binding Site, Ltd. · May 1994
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · Icl Scientific · Jan 1981
ANTISERA TO RABBIT IMMUNOGLOBULIN
K790720 · Kent Laboratories, Inc. · Aug 1979