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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K950817
Device Name DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
Applicant
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHARON HANSEN
Correspondent
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHARON HANSEN
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/22/1995
Decision Date 04/25/1995
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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