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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
510(k) Number K052485
Device Name SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
Applicant
Midi, Inc.
125 Sandy Dr.
Newark,  DE  19713
Applicant Contact WILLIAM STIMSON
Correspondent
Midi, Inc.
125 Sandy Dr.
Newark,  DE  19713
Correspondent Contact WILLIAM STIMSON
Regulation Number866.3045
Classification Product Code
NWZ  
Subsequent Product Codes
KZQ   NPO  
Date Received09/09/2005
Decision Date 01/17/2006
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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