Device Classification Name |
nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
|
510(k) Number |
K200533 |
Device Name |
binx io CT/NG Assay and binx io CT/NG System |
Applicant |
binx health Inc |
77 North Washington Street, 5th Floor |
Boston,
MA
02114
|
|
Applicant Contact |
Sarah Kalil |
Correspondent |
binx health Inc |
77 North Washington Street, 5th Floor |
Boston,
MA
02114
|
|
Correspondent Contact |
Sarah Kalil |
Regulation Number | 866.3393
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/02/2020 |
Decision Date | 04/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03071510
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|