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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, Radioallergosorbent (Rast) Immunological
510(k) Number K112910
Device Name AP 72OS SEMI-AUTOMATED INSTRUMENT
Applicant
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact DONALD POSTEL
Correspondent
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact DONALD POSTEL
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/03/2011
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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