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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K911419
Device Name SENSITITRE ARIS MODULE
Applicant
Sensititre , Ltd.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact LAURA BASISTA
Correspondent
Sensititre , Ltd.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact LAURA BASISTA
Regulation Number866.1640
Classification Product Code
LRG  
Date Received04/01/1991
Decision Date 07/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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