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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K960220
Device Name SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
Applicant
Sensititre , Ltd.
29299 Clements Rd.
Suite 1k
Westlake,  OH  44145
Applicant Contact REBECCA D FIELDS
Correspondent
Sensititre , Ltd.
29299 Clements Rd.
Suite 1k
Westlake,  OH  44145
Correspondent Contact REBECCA D FIELDS
Regulation Number866.1640
Classification Product Code
JWY  
Date Received01/16/1996
Decision Date 03/11/1996
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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