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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Purpose Reagent
510(k) Number K850737
Device Name TRANSPORT CULTURE MEDIUM
Applicant
Roseville Medical Laboratoriesu
729 Sunrise, Blvd.
Suite 600
Roseville,  CA  95678
Applicant Contact LARRY R MCCAIN
Correspondent
Roseville Medical Laboratoriesu
729 Sunrise, Blvd.
Suite 600
Roseville,  CA  95678
Correspondent Contact LARRY R MCCAIN
Regulation Number864.4010
Classification Product Code
PPM  
Date Received02/20/1985
Decision Date 03/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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