Cleared Traditional

K790715 - ANTISERUM TO HUMAN FC

K790715 is an FDA 510(k) clearance for ANTISERUM TO HUMAN FC, manufactured by Kent Laboratories, Inc.. The device is a Class 1 Microbiology device with product code DAS cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K790715 · Kent Laboratories, Inc. · Microbiology device
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Aug 1979
Decision
126d
Days
Class 1
Risk

K790715 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN FC. Classified as Igg (fc Fragment Specific), Antigen, Antiserum, Control (product code DAS), Class I - General 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 Microbiology FDA review panel, regulated under 21 CFR 866.5530 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K790715

510(k) Number K790715 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 Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 102d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

DAS Device Classification - Class 1, General Controls

Product Code DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5530
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.

Regulatory Peers - DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DAS) and FDA review panel - the closest regulatory comparables to K790715.
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · Inova Diagnostics, Inc. · Sep 1998
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600 · The Binding Site, Ltd. · Nov 1989
ANTISERUM TO HUMAN IG G FC FRAGMENTS
K790708 · Kent Laboratories, Inc. · Aug 1979
AMINOGLYCOSIDE CONTROLS
K761156 · Supelco, Inc. · Dec 1976