The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Helicobacter Antigen, Liaison Helicobacter Antigen Control Set.
Device ID | K181464 |
510k Number | K181464 |
Device Name: | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set |
Classification | Helicobacter Pylori |
Applicant | DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
Contact | John C. Walter |
Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
Product Code | LYR |
Subsequent Product Code | JJF |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-04 |
Decision Date | 2018-08-31 |
Summary: | summary |