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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K063838
Device Name LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
Applicant
Thermo Electron OY
Ratastie 2
Vantaa,  FI 01620
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermo Electron OY
Ratastie 2
Vantaa,  FI 01620
Correspondent Contact PAIVI SORMUNEN
Regulation Number866.5600
Classification Product Code
DFC  
Subsequent Product Codes
JIT   JJY  
Date Received12/26/2006
Decision Date 09/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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