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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, direct, nucleic acid amplification, q fever
510(k) Number K103207
Device Name JBAIDS Q FEVER DETECTION KIT
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 Number866.3500
Classification Product Code
OVF  
Date Received11/01/2010
Decision Date 05/20/2011
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
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