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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 K860753
Device Name SENSITITRE SUSCEPTIBILITY PLATES
Applicant
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
231 SUTTON STREET, NORTH
ANDOVER,  MA  01845
Applicant Contact FRANCES M GRIGGS
Correspondent
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
231 SUTTON STREET, NORTH
ANDOVER,  MA  01845
Correspondent Contact FRANCES M GRIGGS
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/27/1986
Decision Date 05/06/1986
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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