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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 a medical device manufactured by Genalyte, Inc.. It received FDA 510(k) clearance on 2019-10-25 under approval 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. It is manufactured by Genalyte, Inc.. The 510(k) number is K191085.

When was Maverick RNP Assay and Maverick Diagnostic System approved by the FDA?

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

What company makes Maverick RNP Assay and Maverick Diagnostic System?

Maverick RNP Assay and Maverick Diagnostic System is manufactured by Genalyte, Inc..

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.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Genalyte, Inc.

K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

Official Source

View on FDA Database →

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

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