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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 K032259
Device Name PASCO MIC AND MIC/ID PANELS
Applicant
Bd Diagnostic Systems
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033 -2440
Applicant Contact LINDA K DILLON
Correspondent
Bd Diagnostic Systems
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033 -2440
Correspondent Contact LINDA K DILLON
Regulation Number866.1640
Classification Product Code
JWY  
Date Received07/22/2003
Decision Date 08/19/2003
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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