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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
Recalls CDRH Recalls
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