Maverick RNP Assay and Maverick Diagnostic System— 510(k) K191085

Name: FDA 510(k) clearance K191085
Creator: U.S. Food and Drug Administration
Published: 2019-10-25

Substantially Equivalent

Genalyte, Inc.

FDA 510(k) clearance K191085 for Maverick RNP Assay and Maverick Diagnostic System, Substantially Equivalent on 2019-10-25. Applicant: Genalyte, Inc.. Device class: 2.

Clearance details

Applicant: Genalyte, Inc.
Product code: Code LKO
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2019-04-24
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX0062007-12-19
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