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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 K893977
Device Name GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
Applicant
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LORRY HUFFMAN
Correspondent
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LORRY HUFFMAN
Regulation Number866.1640
Classification Product Code
JWY  
Date Received06/02/1989
Decision Date 08/15/1989
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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