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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
510(k) Number K111036
Device Name EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
Applicant
MEDICA CORPORATION
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Applicant Contact Photios Makris
Correspondent
MEDICA CORPORATION
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
CDT   CHH   MRR  
Date Received04/14/2011
Decision Date 07/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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