MODIFICATION TO PROFLU+ ASSAY


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K081030
Device Name MODIFICATION TO PROFLU+ ASSAY
Applicant
PRODESSE, INC.
w229 n1870 westwood dr.
waukesha, 
WI 
53186

Applicant Contact karen harrington
Correspondent
PRODESSE, INC.
w229 n1870 westwood dr.
waukesha, 
WI 
53186

Correspodent Contact karen harrington
Regulation Number 866.3980
Classification Product Code
OCC  
Date Received 04/11/2008
Decision Date 05/02/2008
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