Source document or public record
FDA 510(k) K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
FDA 510(k) index record K200506. Device: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. Applicant as listed: Chembio Diagnostic Systems. Decision date: 2020-06-03.
Source
"device_name": "DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K200506.
Device name: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. Applicant as listed: Chembio Diagnostic Systems.
Decision date: 2020-06-03. Decision wording: Substantially Equivalent.
Product code: QFO. Regulation: 21 CFR 866.3935. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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