Cleared Traditional

K912239 - VZVSCAN(TM) LATEX AGGUTINATION TEST
(FDA 510(k) Clearance)

K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology

Jun 1991

Decision

21d

Days

Class 2

Risk

K912239 is an FDA 510(k) clearance for the VZVSCAN(TM) LATEX AGGUTINATION TEST, a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II — Special Controls, product code GQW), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 11, 1991, 21 days after receiving the submission on May 21, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number	K912239 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1991
Decision Date	June 11, 1991
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement