XTAG RESPIRATORY VIRAL PANEL


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K081483
Device Name XTAG RESPIRATORY VIRAL PANEL
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario, 

CA

m5g 1y8

Applicant Contact gloria lee
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario, 

CA

m5g 1y8

Correspodent Contact gloria lee
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received 05/28/2008
Decision Date 06/25/2008
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