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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 K060621
Device Name SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
Applicant
Tds Holdings, Inc.
982 Keynote Circle, Suite 6
Cleveland,  OH  44131
Applicant Contact CYNTHIA C KNAPP
Correspondent
Tds Holdings, Inc.
982 Keynote Circle, Suite 6
Cleveland,  OH  44131
Correspondent Contact CYNTHIA C KNAPP
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Code
LRG  
Date Received03/08/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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