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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 K861888
Device Name HIPPURATE HYDROLYSIS TEST
Applicant
Pro-Lab, Inc.
76 Glengarry Ave.
Toronto
Ontario Canada M5m 1c9,  CA
Applicant Contact LYNN RAE
Correspondent
Pro-Lab, Inc.
76 Glengarry Ave.
Toronto
Ontario Canada M5m 1c9,  CA
Correspondent Contact LYNN RAE
Regulation Number866.2660
Classification Product Code
JTO  
Date Received05/16/1986
Decision Date 06/03/1986
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
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