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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, Single Biochemical Test
510(k) Number K862392
Device Name BIOTIS MOTILITY TEST MEDIUM
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 Number866.2320
Classification Product Code
JSF  
Date Received06/24/1986
Decision Date 07/03/1986
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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