The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Memed Bv, Liaison Memed Bv Control Set.
Device ID | K213936 |
510k Number | K213936 |
Device Name: | LIAISON MeMed BV, LIAISON MeMed BV Control Set |
Classification | Immunoassay For Host Biomarkers Of Infection |
Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
Contact | John C. Walter |
Correspondent | Emily Peterson DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
Product Code | QPS |
CFR Regulation Number | 866.3215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-16 |
Decision Date | 2022-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08056771602976 | K213936 | 000 |
08056771602969 | K213936 | 000 |