Cleared Traditional

K850686 - ANTISERUM TO HUMAN PREALBUMIN
(FDA 510(k) Clearance)

K850686 · Kent Laboratories, Inc. · Immunology

Nov 1985

Decision

253d

Days

Class 1

Risk

K850686 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN PREALBUMIN, a Prealbumin, Antigen, Antiserum, Control (Class I — General Controls, product code JZJ), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 1, 1985, 253 days after receiving the submission on February 21, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number	K850686 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1985
Decision Date	November 01, 1985
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—