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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K950346
Device Name B-L RED(TM) DISCS
Applicant
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217
Applicant Contact LYNDA M TAYLOR
Correspondent
Oxis Intl., Inc.
6040 N. Cutter Cir., #317
Portland,  OR  97217
Correspondent Contact LYNDA M TAYLOR
Regulation Number866.2660
Classification Product Code
JTO  
Date Received01/27/1995
Decision Date 05/05/1995
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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