Cleared Traditional

K790706 - ANTISERUM TO RABBIT IGG H & L CHAIN

K790706 is the FDA 510(k) clearance for ANTISERUM TO RABBIT IGG H & L CHAIN by Kent Laboratories, Inc.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K790706 · Kent Laboratories, Inc. · Immunology device
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Sep 1979
Decision
153d
Days
Class 2
Risk

K790706 is an FDA 510(k) clearance for the ANTISERUM TO RABBIT IGG H & L CHAIN. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 K790706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1979
Decision Date September 12, 1979
Days to Decision 153 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
49d slower than avg
Panel avg: 104d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 39
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K790706.
DAKO PAP KIT K504
K812485 · Dako Corp. · Feb 1982
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · Dako Corp. · Sep 1981
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · Kallestad Laboratories, Inc. · Oct 1980
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · Icl Scientific · Jul 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · Icl Scientific · Jul 1978