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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 K122722
Device Name COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact LISA K KLINEDINST
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact LISA K KLINEDINST
Regulation Number866.5600
Classification Product Code
DFC  
Subsequent Product Codes
JIT   JJX  
Date Received09/05/2012
Decision Date 11/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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