Cleared Traditional

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY

K853540 · Idt, A Division of Whittaker M.A. Bioproducts · Microbiology

Feb 1986

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K853540 is an FDA 510(k) clearance for the FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY, a Antiserum, Cf, Varicella-zoster (Class II — Special Controls, product code GQX), submitted by Idt, A Division of Whittaker M.A. Bioproducts (San Jose, US). The FDA issued a Cleared decision on February 4, 1986, 165 days after receiving the submission on August 23, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number	K853540 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 1985
Decision Date	February 04, 1986
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—