The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Osom Mono Test; Sure Vue Signature Mono; Immunocard Stat Mono; Cardinal Health Mono Ii Rapid Test.
| Device ID | K181436 |
| 510k Number | K181436 |
| Device Name: | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 |
| Contact | Shelly Harris |
| Correspondent | Shelly Harris Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-06-22 |
| Summary: | summary |