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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Anaerobic Identification
510(k) Number K945487
Device Name LYFO(TM) DIFFERENTIAL DISK
Applicant
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303 -4452
Applicant Contact GERI HOTZ
Correspondent
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303 -4452
Correspondent Contact GERI HOTZ
Regulation Number866.2660
Classification Product Code
JSP  
Date Received11/08/1994
Decision Date 05/11/1995
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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