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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 K940917
Device Name LORACARBEF GRAM-NAGATIVE PANELS
Applicant
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact ELAINE K CATAPANE
Correspondent
Baxter Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact ELAINE K CATAPANE
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/25/1994
Decision Date 02/08/1995
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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