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510(k) K092633

OSOM INFLUENZA A&B TEST , MODEL PN190 by Genzyme Corporation — Product Code PSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2009
Date Received
August 27, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices Detecting Influenza A, B, And C Virus Antigens
Device Class
Class II
Regulation Number
866.3328
Review Panel
MI
Submission Type

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.

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  • K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT (July 11, 2005)

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