Cleared Traditional

K842661 - ANTI-CYTOMEGALOVIRUS KIT
(FDA 510(k) Clearance)

K842661 · Amico Lab, Inc. · Immunology

Dec 1985

Decision

514d

Days

Class 2

Risk

K842661 is an FDA 510(k) clearance for the ANTI-CYTOMEGALOVIRUS KIT. This device is classified as a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI).

Submitted by Amico Lab, Inc.. The FDA issued a Cleared decision on December 6, 1985, 514 days after receiving the submission on July 10, 1984.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K842661 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1984
Decision Date	December 06, 1985
Days to Decision	514 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—