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 |