DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader— 510(k) K200506
Substantially EquivalentChembio Diagnostic Systems
FDA 510(k) clearance K200506 for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader, Substantially Equivalent on 2020-06-03. Applicant: Chembio Diagnostic Systems.
Clearance details
- Applicant
- Chembio Diagnostic Systems
- Product code
- Code QFO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medford, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.