The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Xl Zika Capture Igm Ii And Liaison Xl Zika Capture Igm Ii Control Set.
Device ID | K192046 |
510k Number | K192046 |
Device Name: | LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set |
Classification | Zika Virus Serological Reagents |
Applicant | DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
Contact | John C. Walter |
Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
Product Code | QFO |
CFR Regulation Number | 866.3935 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-31 |
Decision Date | 2019-10-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08056771602648 | K192046 | 000 |
08056771602624 | K192046 | 000 |