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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 K850722
Device Name MARTIN LEWIS AGAR
Applicant
Rapid City Regional Hospital, Inc.
353 Fairmont Blvd.
Rapid City,  SD  57701
Applicant Contact SHEILA M HILLBERRY
Correspondent
Rapid City Regional Hospital, Inc.
353 Fairmont Blvd.
Rapid City,  SD  57701
Correspondent Contact SHEILA M HILLBERRY
Regulation Number866.2410
Classification Product Code
JTY  
Date Received02/22/1985
Decision Date 03/22/1985
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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