Cleared Traditional

LPIA-FERRITIN ASSAY

K924186 · Seradyn, Inc. · Immunology

Dec 1992

Decision

125d

Days

Class 1

Risk

About This 510(k) Submission

K924186 is an FDA 510(k) clearance for the LPIA-FERRITIN ASSAY, a Alpha-2-hs-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code DEF), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 23, 1992, 125 days after receiving the submission on August 20, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5425.

Submission Details

510(k) Number	K924186 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1992
Decision Date	December 23, 1992
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF