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 Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/11/2019 |
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
|
|
|