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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
510(k) Number K212204
Device Name Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Applicant
Cd Diagnostics, Inc.
650 Naamans Rd.
Suite 100
Claymont,  DE  19703
Applicant Contact Pragnya Bakka
Correspondent
Cd Diagnostics, Inc.
650 Naamans Rd.
Suite 100
Claymont,  DE  19703
Correspondent Contact Pragnya Bakka
Classification Product Code
QGN  
Date Received07/15/2021
Decision Date 08/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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