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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K031601
Device Name MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
Applicant
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact ROBERT EUSEBIO
Correspondent
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact ROBERT EUSEBIO
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
JWY   LRG   LTT   LTW  
Date Received05/21/2003
Decision Date 04/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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