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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 K861022
Device Name KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
Applicant
MICRO-BIO-LOGICS
217 OSSEO AVENUE NORTH
ST. CLOUD,  MN  56301
Applicant Contact GERALD TJERNAGEL
Correspondent
MICRO-BIO-LOGICS
217 OSSEO AVENUE NORTH
ST. CLOUD,  MN  56301
Correspondent Contact GERALD TJERNAGEL
Regulation Number866.2480
Classification Product Code
JTR  
Date Received03/18/1986
Decision Date 04/04/1986
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
Recalls CDRH Recalls
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