FDA 510(k) Application Details - K103207

Device Classification Name

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510(K) Number K103207
Device Name JBAIDS Q FEVER DETECTION KIT
Applicant IDAHO TECHNOLOGY, INC.
390 Wakara Way
Salt Lake City, UT 84108 US
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Contact BETH LINGENFELTER
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Regulation Number

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Classification Product Code OVF
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Date Received 11/01/2010
Decision Date 05/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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