FILMARRAY RP PANEL


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K110764
Device Name FILMARRAY RP PANEL
Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city, 
UT 
84108

Applicant Contact beth lingenfelter
Correspondent
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city, 
UT 
84108

Correspodent Contact beth lingenfelter
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NXD   OEM   OEP   OOI   OOU  
OTG  
Date Received 03/18/2011
Decision Date 04/27/2011
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