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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 Differential
510(k) Number K855110
Device Name DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
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
JSI  
Date Received12/23/1985
Decision Date 01/07/1986
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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