Cedia Carbamazepine Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K914857

Identifiers

510(k) Number: K914857 FDA 510(k)
FDA Product Code: KLT FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3645 FDA 510(k)
Regulation Number: 862.3645 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Cedia Carbamazepine Assay is an enzyme immunoassay, a type of device used for therapeutic drug monitoring. It is designed to measure the level of carbamazepine in a sample. The assay uses a homogeneous enzyme immunoassay system based on the bacterial enzyme -galactosidase.

The Cedia Carbamazepine Assay is supplied with a product code of KLT and is regulated under the code 862.3645. It has been cleared under the FDA 510K number K914857. The device is intended for use in clinical toxicology and is available for use on a wide range of analyzers.

Frequently asked questions

What is the Cedia Carbamazepine Assay used for?

The Cedia Carbamazepine Assay is used for therapeutic drug monitoring to measure the level of carbamazepine in a sample, intended for use in clinical toxicology.

How is the Cedia Carbamazepine Assay supplied?

The Cedia Carbamazepine Assay is supplied with a product code of KLT and is available for use on a wide range of analyzers.

Is the Cedia Carbamazepine Assay cleared by the FDA?

Yes, the Cedia Carbamazepine Assay has been cleared under the FDA 510K number K914857, determined to be substantially equivalent.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CEDIA™ Therapeutic Drug Monitoring (TDM) Assays Carbamazepine Assay ..., CEDIA (R) CARBAMAZEPINE ASSAY 510 (k) K914857 - FDA.report, PDF CEDIATM Carbamazepine II Assay - assets.fishersci.com, PDF K914857 CEDIA(R) CARBAMAZEPINE ASSAY - 510kdatabase.net, PDF Cedia Carbamazepine Ii Application - Beckman Coulter Au680

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K914857	Class II	Active

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Manufacturer

Manufacturer: Microgenics Corporation
FDA Applicant: Microgenics Corp.

Sources (1)

FDA 510(k) K914857 24 fields · synced Sep 21, 2026