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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K191514
Device Name CareStart Flu A&B Plus
Applicant
Access Bio, Inc.
65 Clyde Rd., Suite A.
Somerset,  NJ  08873
Applicant Contact Sang Joon Han
Correspondent
Access Bio, Inc.
65 Clyde Rd., Suite A.
Somerset,  NJ  08873
Correspondent Contact Jongrak Kim
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received06/07/2019
Decision Date 02/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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