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 |