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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Positive Identification Panel
510(k) Number K874606
Device Name CATHRA GRAM POSITIVE SCREEN
Applicant
Mct Medical, Inc.
599 Cardigan Rd.
P.O. Box 64022
Shoreview,  MN  55126
Applicant Contact ANN WEAVER
Correspondent
Mct Medical, Inc.
599 Cardigan Rd.
P.O. Box 64022
Shoreview,  MN  55126
Correspondent Contact ANN WEAVER
Regulation Number866.2660
Classification Product Code
LQL  
Date Received11/09/1987
Decision Date 05/06/1988
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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