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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Quality Control For Culture Media
510(k) Number K855198
Device Name INDI KWIK (TM) CO/TWO KIT
Applicant
Micro-Bio-Logics
217 Osseo Ave. N.
St. Cloud,  MN  56301
Applicant Contact GERALD TJERNAGEL
Correspondent
Micro-Bio-Logics
217 Osseo Ave. N.
St. Cloud,  MN  56301
Correspondent Contact GERALD TJERNAGEL
Regulation Number866.2480
Classification Product Code
JTR  
Date Received12/27/1985
Decision Date 01/14/1986
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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