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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, propoxyphene
510(k) Number K111363
Model 14248, 14880, 14881, 14882, 14883, 14884, 14786, 14787
Device Name PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
Original Applicant
MEDICA CORP.
5 oak park drive
bedford,  MA  01730
Original Contact photios makris
Regulation Number862.3700
Classification Product Code
JXN  
Subsequent Product Codes
DLJ   LAS  
Date Received05/16/2011
Decision Date 12/06/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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