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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K945880
Device Name LYFO(TM) DIFFERENTIAL DISK-SPS
Applicant
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303
Applicant Contact GERI HOTZ
Correspondent
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303
Correspondent Contact GERI HOTZ
Regulation Number866.2660
Classification Product Code
JTO  
Date Received12/01/1994
Decision Date 04/24/1995
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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