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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K122398
Device Name RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Applicant
Siemens Healthcare Diagnostics Inc.
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Applicant Contact Amy Goldberg
Correspondent
Siemens Healthcare Diagnostics Inc.
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Correspondent Contact Noor Malki
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/07/2012
Decision Date 10/12/2012
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
Recalls CDRH Recalls
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