Cleared Traditional

K842662 - ANTI-EPSTEIN-BARR VIRUS KIT
(FDA 510(k) Clearance)

K842662 · Amico Lab, Inc. · Immunology

Dec 1985

Decision

520d

Days

Class 1

Risk

K842662 is an FDA 510(k) clearance for the ANTI-EPSTEIN-BARR VIRUS KIT. This device is classified as a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP).

Submitted by Amico Lab, Inc.. The FDA issued a Cleared decision on December 12, 1985, 520 days after receiving the submission on July 10, 1984.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K842662 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1984
Decision Date	December 12, 1985
Days to Decision	520 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—