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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 K843817
Device Name BIOTIS MARTIN LEWIS AGAR
Applicant
Otisville Biotech, Inc.
P.O. Box 567
Otisville,  NY  10963
Applicant Contact ERNEST M GREEN
Correspondent
Otisville Biotech, Inc.
P.O. Box 567
Otisville,  NY  10963
Correspondent Contact ERNEST M GREEN
Regulation Number866.2410
Classification Product Code
JTY  
Date Received09/28/1984
Decision Date 10/10/1984
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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