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

FDA 510(k)

Alinity c Benzodiazepines Reagent Kit

K-Number: K243498 · 2024-12-11

ApplicantMicrogenics Corporation
Decision Date2024-12-11
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Alinity c Benzodiazepines Reagent Kit is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2024-12-11 under approval number K243498. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity c Benzodiazepines Reagent Kit?

Alinity c Benzodiazepines Reagent Kit is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Microgenics Corporation. The 510(k) number is K243498.

When was Alinity c Benzodiazepines Reagent Kit approved by the FDA?

Alinity c Benzodiazepines Reagent Kit received FDA 510(k) clearance on 2024-12-11, under approval number K243498.

What company makes Alinity c Benzodiazepines Reagent Kit?

Alinity c Benzodiazepines Reagent Kit is manufactured by Microgenics Corporation.

What is the FDA product code for Alinity c Benzodiazepines Reagent Kit?

The FDA product code for Alinity c Benzodiazepines Reagent Kit is JXM.

Other Devices by Microgenics Corporation

K173183CEDIA Heroin Metabolite (6-AM) Assay K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set DEN180030QMS Plazomicin Immunoassay K181499DRI Cocaine Metabolite Assay K173963DRI Benzodiazepine Assay K173195DRI Hydrocodone Assay

View all 14 devices →

Related Devices (Code: JXM)

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K173963DRI Benzodiazepine AssayMicrogenics Corporation K190968CEDIA Benzodiazepine AssayMicrogenics Corporation

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.

↑