XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K103776
Device Name XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
suite 900
toronto, ontario, 

CA

m5g 1y8

Applicant Contact lubna syed
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
suite 900
toronto, ontario, 

CA

m5g 1y8

Correspodent Contact lubna syed
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received 12/27/2010
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No