Cleared Traditional

ANTISERA TO HUMAN FRAGMENT

K790711 · Kent Laboratories, Inc. · Immunology

Sep 1979

Decision

145d

Days

Class 1

Risk

About This 510(k) Submission

K790711 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FRAGMENT, a Igg (fab Fragment Specific), Antigen, Antiserum, Control (Class I — General Controls, product code DFK), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979, 145 days after receiving the submission on April 12, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5520.

Submission Details

510(k) Number	K790711 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 1979
Decision Date	September 04, 1979
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—