Cleared Traditional

K903882 - VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
(FDA 510(k) Clearance)

K903882 · Viral Antigens, Inc. · Microbiology

Dec 1990

Decision

104d

Days

Class 2

Risk

K903882 is an FDA 510(k) clearance for the VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG. This device is classified as a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II — Special Controls, product code GQW).

Submitted by Viral Antigens, Inc. (Memphis, US). The FDA issued a Cleared decision on December 4, 1990, 104 days after receiving the submission on August 22, 1990.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number	K903882 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 1990
Decision Date	December 04, 1990
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—