XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K112199
Device Name XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
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
NSU   OEM   OEP  
Date Received 08/01/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No