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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K010455
Device Name ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
Applicant
Diagnostica-Stago
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact ANDREW LOC B LE
Correspondent
Diagnostica-Stago
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact ANDREW LOC B LE
Regulation Number864.7525
Classification Product Code
KFF  
Date Received01/29/2001
Decision Date 06/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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