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FDA 510(k)

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

K-Number: K200506 · 2020-06-03

ApplicantChembio Diagnostic Systems
Decision Date2020-06-03
Product CodeQFO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is a medical device manufactured by Chembio Diagnostic Systems. It received FDA 510(k) clearance on 2020-06-03 under approval number K200506. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Chembio Diagnostic Systems. The 510(k) number is K200506.

When was DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader approved by the FDA?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader received FDA 510(k) clearance on 2020-06-03, under approval number K200506.

What company makes DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is manufactured by Chembio Diagnostic Systems.

What is the FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is QFO.

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Related Devices (Code: QFO)

K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc. K191578ADVIA 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 ControlSiemens Healthcare Diagnostics, Inc. DEN180069ZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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