510(k) DEN180069
- Device
- ZIKV Detect 2.0 IgM Capture ELISA
- Applicant
- InBios International, Inc.
- 510(k) number
- DEN180069
- Product code
- QFO
- Decision
- Unknown (DENG)
- Decision date
- 2019-05-23
- Date received
- 2018-12-26
- Regulation
- 866.3935
- Classification name
- Zika Virus Serological Reagents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Estela Raychaudhuri
- Address
- 307 Westlake Ave. N, Suite 300 Seattle WA US 98109 98109
FDA Registration Numbers#
- 2432235
- 2243471
- 2182595
- 2431980
- 3026565854
- 2032839
- 1219913
- 3032562
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | DiaSorin, Inc. | 2019-10-28 |
| 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 |