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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K143470
Device Name Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number864.7340
Classification Product Code
GIS  
Subsequent Product Codes
GFX   GIL  
Date Received12/05/2014
Decision Date 01/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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