Source document or public record
FDA 510(k) K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
FDA 510(k) index record K213236. Device: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel. Applicant as listed: Genmark Diagnostics, Incorporated. Decision date: 2022-04-27.
Source
"device_name": "ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel"
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 K213236.
Device name: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel. Applicant as listed: Genmark Diagnostics, Incorporated.
Decision date: 2022-04-27. Decision wording: Substantially Equivalent.
Product code: PEN. Regulation: 21 CFR 866.3365. 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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