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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
510(k) Number K020689
Device Name SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
Applicant
MIDI, INC.
125 SANDY DR.
NEWARK,  DE  19713 -1148
Applicant Contact WILLIAMS STIMSON
Correspondent
MIDI, INC.
125 SANDY DR.
NEWARK,  DE  19713 -1148
Correspondent Contact WILLIAMS STIMSON
Regulation Number866.3370
Classification Product Code
NJO  
Date Received03/04/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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