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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 K921637
Device Name ESP BLOOD CULTURE SYSTEM
Applicant
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Applicant Contact JERRY W SMITH
Correspondent
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Correspondent Contact JERRY W SMITH
Regulation Number866.2560
Classification Product Code
MDB  
Date Received04/06/1992
Decision Date 07/14/1992
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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