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 |