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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K120267
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
Correspondent Contact BETH LINGENFELTER
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NXD   OEM   OEP   OOI   OOU  
OTG   OZX   OZY   OZZ  
Date Received01/30/2012
Decision Date 05/15/2012
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
Predetermined Change
Control Plan Authorized		 No
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