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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 the device name listed in this FDA 510(k) record. The listed applicant is Chembio Diagnostic Systems. It received FDA 510(k) clearance on 2020-06-03 under 510(k) 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. The listed applicant is Chembio Diagnostic Systems. The 510(k) number is K200506.

When did DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader receive FDA 510(k) clearance?

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

Who is the listed applicant for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA 510(k) record lists Chembio Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: QFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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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