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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation For Clinical Multiplex Test Systems
510(k) Number K082562
Device Name APPLIED BIOSYSTEMS 7500 FAST DX
Applicant
Applied Biosystems, Inc.
850 Lincoln Center Dr.
Foster City,  CA  94404 -1128
Applicant Contact JOHN D'ANGELO
Correspondent
Applied Biosystems, Inc.
850 Lincoln Center Dr.
Foster City,  CA  94404 -1128
Correspondent Contact JOHN D'ANGELO
Regulation Number862.2570
Classification Product Code
NSU  
Date Received09/04/2008
Decision Date 09/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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