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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K181443
Device Name Accula RSV Test
Applicant
Mesa Biotech, Inc.
6190 Cornerstone Court, Suite 220
san diego,  CA  92121
Applicant Contact barbara stevens
Correspondent
Mesa Biotech, Inc.
6190 Cornerstone Court, Suite 220
san diego,  CA  92121
Correspondent Contact barbara stevens
Regulation Number866.3980
Classification Product Code
OCC  
Date Received05/31/2018
Decision Date 11/23/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
CLIA Waiver CLIA Waiver Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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