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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K083175
Device Name BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Applicant Contact JANET M FOSE
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Correspondent Contact JANET M FOSE
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Codes
GGC   GIZ  
Date Received10/28/2008
Decision Date 01/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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