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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
510(k) Number K201269
Device Name Accula Strep A Test
Applicant
Mesa Biotech, Inc.
6190 Cornerstone Ct.
Suite 220
San Diego,  CA  92121
Applicant Contact Barbara Stevens
Correspondent
Mesa Biotech, Inc.
6190 Cornerstone Ct.
Suite 220
San Diego,  CA  92121
Correspondent Contact Barbara Stevens
Regulation Number866.2680
Classification Product Code
PGX  
Date Received05/12/2020
Decision Date 11/09/2020
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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