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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 K874876
Device Name GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
Applicant
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact TODD A WOODRING
Correspondent
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact TODD A WOODRING
Regulation Number866.1640
Classification Product Code
JWY  
Date Received11/30/1987
Decision Date 01/11/1988
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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