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. Device class: 2.
Clearance details
- Applicant
- Chembio Diagnostic Systems
- Product code
- Code QFO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3935
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medford, NY, US
Recent devices under product code QFO
view all- K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- 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
- DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.