Cepheid Xpert CT/NG Control Panel— 510(k) K190223

Name: FDA 510(k) clearance K190223
Creator: U.S. Food and Drug Administration
Published: 2019-05-08

Substantially Equivalent

Microbiologics, Inc.

FDA 510(k) clearance K190223 for Cepheid Xpert CT/NG Control Panel, Substantially Equivalent on 2019-05-08. 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: 2019-02-05
Decision date: 2019-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, US

Download summary PDF View on FDA.gov ↗

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