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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg (Gamma Chain Specific), Antigen, Antiserum, Control
510(k) Number K092283
FOIA Releasable 510(k) K092283
Device Name DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Applicant Contact KATHLEEN ANN DRAY-LYONS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Correspondent Contact KATHLEEN ANN DRAY-LYONS
Regulation Number866.5510
Classification Product Code
DFZ  
Date Received07/29/2009
Decision Date 10/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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