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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 K880641
Device Name SENSITITRE STABILITY PLATES
Applicant
Sensititre , Ltd.
8a Industrial Way #2
Salem,  NH  03079
Applicant Contact FRANCES M GRIGGS
Correspondent
Sensititre , Ltd.
8a Industrial Way #2
Salem,  NH  03079
Correspondent Contact FRANCES M GRIGGS
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/11/1988
Decision Date 05/13/1988
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
Recalls CDRH Recalls
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