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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Blood Culturing
510(k) Number K953129
Device Name ESP CULTURE SYSTEM - MYCO
Applicant
Difco Laboratories, Inc.
17197 N. Laurel Park
Suite 400
Livouia,  MI  48152
Applicant Contact DAVID W GATES
Correspondent
Difco Laboratories, Inc.
17197 N. Laurel Park
Suite 400
Livouia,  MI  48152
Correspondent Contact DAVID W GATES
Regulation Number866.2560
Classification Product Code
MDB  
Date Received07/06/1995
Decision Date 12/26/1995
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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