Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

K-Number: K234091 · 2024-07-22

ApplicantGenalyte, Inc.
Decision Date2024-07-22
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is the device name listed in this FDA 510(k) record. The listed applicant is Genalyte, Inc.. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K234091. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Genalyte, Inc.. The 510(k) number is K234091.

When did Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 receive FDA 510(k) clearance?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 received FDA 510(k) clearance on 2024-07-22, under 510(k) number K234091.

Who is the listed applicant for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

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 Diagnostic System TC1000; Maverick Test Panel A0.B0?

The FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is JLW.

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.

K191085Maverick RNP Assay and Maverick Diagnostic System

Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.K190773Elecsys TSHRoche Diagnostics

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.

↑