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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, For Isolation Of Pathogenic Neisseria
510(k) Number K850732
Device Name CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI
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 Number866.2410
Classification Product Code
JTY  
Date Received02/20/1985
Decision Date 03/20/1985
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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