Cleared Traditional

K842529 - AMIZYME-CMV KIT
(FDA 510(k) Clearance)

K842529 · Amico Lab, Inc. · Immunology

Dec 1985

Decision

526d

Days

Class 2

Risk

K842529 is an FDA 510(k) clearance for the AMIZYME-CMV 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, 526 days after receiving the submission on June 28, 1984.

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

Submission Details

510(k) Number	K842529 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1984
Decision Date	December 06, 1985
Days to Decision	526 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—