The following data is part of a premarket notification filed by Binx Health, Inc. with the FDA for Binx Health Io Ct/ng Assay.
Device ID | K191352 |
510k Number | K191352 |
Device Name: | Binx Health Io CT/NG Assay |
Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
Applicant | binx Health, Inc. 77 N. Washington Street, 5th Floor Boston, MA 02114 |
Contact | Sarah Kalil |
Correspondent | Sarah Kalil binx Health, Inc. 77 N. Washington Street, 5th Floor Boston, MA 02114 |
Product Code | QEP |
Subsequent Product Code | LSL |
Subsequent Product Code | MKZ |
Subsequent Product Code | NSU |
CFR Regulation Number | 866.3393 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-20 |
Decision Date | 2019-08-08 |