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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 K861734
Device Name REGAN-LOWE AGAR
Applicant
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Applicant Contact GREGG BURMEISTER
Correspondent
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Correspondent Contact GREGG BURMEISTER
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received05/06/1986
Decision Date 05/16/1986
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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