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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, Enriched
510(k) Number K874177
Device Name BIOTIS (TM) BCYE
Applicant
Otisville Biopharm, Inc.
P.O. Box 567 Sanatorium Rd.
Otisville,  NY  10963
Applicant Contact PAT MULHOLLAND
Correspondent
Otisville Biopharm, Inc.
P.O. Box 567 Sanatorium Rd.
Otisville,  NY  10963
Correspondent Contact PAT MULHOLLAND
Regulation Number866.2330
Classification Product Code
KZI  
Date Received10/15/1987
Decision Date 12/04/1987
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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