Cepheid Xpert C. difficile/Epi Control Panel— 510(k) K190463

Name: FDA 510(k) clearance K190463
Creator: U.S. Food and Drug Administration
Published: 2019-04-19

Substantially Equivalent

Microbiologics, Inc.

FDA 510(k) clearance K190463 for Cepheid Xpert C. difficile/Epi Control Panel, Substantially Equivalent on 2019-04-19. Applicant: Microbiologics, Inc.. Device class: 2.

Clearance details

Applicant: Microbiologics, Inc.
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2019-02-26
Decision date: 2019-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K190463

K-number listed on FDA's recall record

Z-1838-2019 — Cepheid Xpert C. difficile/Epi Control PanelClass III·Ongoing·Microbiologics Inc·20190516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190463.

Data sourced from openFDA. This site is unofficial and independent of the FDA.