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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K193041
Device Name Hemochron Signature Elite
Applicant
Accriva Diagnostics, Inc.
6260 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Brian James
Correspondent
Accriva Diagnostics, Inc.
6260 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Brian James
Regulation Number864.5425
Classification Product Code
JPA  
Date Received10/31/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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