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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K150031
Device Name hemoFISH Masterpanel
Applicant
MIACOM DIAGNOSTICS GMBH
MEROWINGERPLATZ 1A
DUSSELDORF,  DE 40225
Applicant Contact EVE BLOMEKE
Correspondent
MIACOM DIAGNOSTICS GMBH
MEROWINGERPLATZ 1A
DUSSELDORF,  DE 40225
Correspondent Contact EVE BLOMEKE
Regulation Number866.2660
Classification Product Code
JSS  
Subsequent Product Codes
MCS   MDK  
Date Received01/08/2015
Decision Date 10/01/2015
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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