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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 K180074
Device Name Diazyme Lipoprotein (a) Assay
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Court
Poway,  CA  92130
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Court
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number866.5600
Classification Product Code
DFC  
Date Received01/10/2018
Decision Date 03/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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