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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
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