FDA 510(k) Application Details - K072547

Device Classification Name Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

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510(K) Number K072547
Device Name Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia 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 866.3280

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Classification Product Code OEH
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Date Received 09/10/2007
Decision Date 12/19/2007
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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