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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
510(k) Number K190613
Device Name BD MAX Check-Points CPO
Applicant
Check-Points Health B.V.
Binnenhaven 5
Wageningen,  NL 6709
Applicant Contact Pieter Vos
Correspondent
Check-Points Health B.V.
Binnenhaven 5
Wageningen,  NL 6709
Correspondent Contact Pieter Vos
Regulation Number866.1640
Classification Product Code
POC  
Subsequent Product Code
OOI  
Date Received03/11/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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