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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Selective And Non-Differential
510(k) Number K870134
Device Name MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
Applicant
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Applicant Contact GREGG G BURMEISTER
Correspondent
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Correspondent Contact GREGG G BURMEISTER
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received01/13/1987
Decision Date 02/04/1987
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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