Cleared Traditional

BD DIRECTIGEN FLU A+B

K001364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology

Jun 2000

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K001364 is an FDA 510(k) clearance for the BD DIRECTIGEN FLU A+B, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on June 28, 2000, 58 days after receiving the submission on May 1, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K001364 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2000
Decision Date	June 28, 2000
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3328
Definition	An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.