Cleared Traditional

ANTI SERA TO HUMAN OROSCOMUCOID

K823765 · Kent Laboratories, Inc. · Immunology
Dec 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823765 is an FDA 510(k) clearance for the ANTI SERA TO HUMAN OROSCOMUCOID, a Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code DEX), submitted by Kent Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982, 16 days after receiving the submission on December 14, 1982. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K823765 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1982
Decision Date December 30, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEX — Alpha-1-b-glycoprotein, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5420