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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K113216
Device Name RAPIDPOINT 500 BLOOD GAS ANALYER
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Applicant Contact Steven Goldberg
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Correspondent Contact Steven Goldberg
Regulation Number862.1450
Classification Product Code
KHP  
Date Received11/01/2011
Decision Date 05/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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