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FDA 510(k)

Maverick RNP Assay and Maverick Diagnostic System

K-Number: K191085 · 2019-10-25

ApplicantGenalyte, Inc.
Decision Date2019-10-25
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Maverick RNP Assay and Maverick Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Genalyte, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191085. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maverick RNP Assay and Maverick Diagnostic System?

Maverick RNP Assay and Maverick Diagnostic System is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Genalyte, Inc.. The 510(k) number is K191085.

When did Maverick RNP Assay and Maverick Diagnostic System receive FDA 510(k) clearance?

Maverick RNP Assay and Maverick Diagnostic System received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191085.

Who is the listed applicant for Maverick RNP Assay and Maverick Diagnostic System?

The FDA 510(k) record lists Genalyte, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maverick RNP Assay and Maverick Diagnostic System?

The FDA product code for Maverick RNP Assay and Maverick Diagnostic System is LKO.

Other records listing Genalyte, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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