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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulase, Human, Horse And Rabbit
510(k) Number K861312
Device Name LYFO-KWIK (TM) COAGULASE PLASMA
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 Number866.2160
Classification Product Code
JTL  
Date Received04/08/1986
Decision Date 04/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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