The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Osom Influenza A&b Test Model 190.
Device ID | K123182 |
510k Number | K123182 |
Device Name: | OSOM INFLUENZA A&B TEST MODEL 190 |
Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
Applicant | SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
Contact | Mark Stavro |
Correspondent | Mark Stavro SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
Product Code | GNX |
CFR Regulation Number | 866.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-10 |
Decision Date | 2012-11-05 |
Summary: | summary |