Cleared Special

OSOM INFLUENZA A&B TEST , MODEL PN190

K092633 · Genzyme Corporation · Microbiology

Sep 2009

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K092633 is an FDA 510(k) clearance for the OSOM INFLUENZA A&B TEST , MODEL PN190, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on September 25, 2009, 29 days after receiving the submission on August 27, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K092633 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2009
Decision Date	September 25, 2009
Days to Decision	29 days
Submission Type	Special
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.