510(k) K200506
- Device
- DPP Zika IgM System, DPP Zika IgM System Control Pack, And DPP Micro Reader
- Applicant
- Chembio Diagnostic Systems
- 510(k) number
- K200506
- Product code
- QFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-06-03
- Date received
- 2020-03-02
- 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
- Louise Muscat Sigismondi
- Address
- 3661 Horseblock Rd. Medford NY US 11763 11763
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 |
|---|---|---|---|
| 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 |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019-05-23 |
Legacy Summary#
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FDA Review#
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