510(k) K192046
- Device
- LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set
- Applicant
- DiaSorin Inc.
- 510(k) number
- K192046
- Product code
- QFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-28
- Date received
- 2019-07-31
- Regulation
- 866.3935
- Classification name
- Zika Virus Serological Reagents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John C. Walter
- Address
- 1951 Northwestern Ave. Stillwater MN US 55082 55082
FDA Registration Numbers#
- 2032839
- 2431980
- 3026565854
- 2432235
- 2182595
- 3032562
- 2243471
- 1219913
Source Documents#
Other 510(k) Records For Product Code QFO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Chembio Diagnostic Systems | 2020-06-03 |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019-05-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary