Cleared Traditional

K790711 - ANTISERA TO HUMAN FRAGMENT

K790711 is an FDA 510(k) clearance for ANTISERA TO HUMAN FRAGMENT, manufactured by Kent Laboratories, Inc.. The device is a Class 1 Immunology device with product code DFK cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K790711 · Kent Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
145d
Days
Class 1
Risk

K790711 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FRAGMENT. Classified as Igg (fab Fragment Specific), Antigen, Antiserum, Control (product code DFK), Class I - General 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 866.5520 - 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 - K790711

510(k) Number K790711 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
40d slower than avg
Panel avg: 105d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

DFK Device Classification - Class 1, General Controls

Product Code DFK Igg (fab Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.