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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K855172
Device Name KWI (TM) G-CO/TWO
Applicant
Micro-Bio-Logics
217 Osseo Ave. N.
St. Cloud,  MN  56301
Applicant Contact OERALD TJERNAGEL
Correspondent
Micro-Bio-Logics
217 Osseo Ave. N.
St. Cloud,  MN  56301
Correspondent Contact OERALD TJERNAGEL
Regulation Number866.2450
Classification Product Code
JSK  
Date Received12/26/1985
Decision Date 02/20/1986
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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