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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
Model 05852625190; 058525641160; 05852650160
Device Name COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Original Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Original 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 - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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