Cleared Traditional

K790706 - ANTISERUM TO RABBIT IGG H & L CHAIN
(FDA 510(k) Clearance)

K790706 · Kent Laboratories, Inc. · Immunology

Sep 1979

Decision

153d

Days

Class 2

Risk

K790706 is an FDA 510(k) clearance for the ANTISERUM TO RABBIT IGG H & L CHAIN, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979, 153 days after receiving the submission on April 12, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number	K790706 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 1979
Decision Date	September 12, 1979
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—