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Candida Detection System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K823016

by Ramco Laboratories, Inc.

Identifiers

510(k) Number
K823016 FDA 510(k)
FDA Product Code
LHK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3165 FDA 510(k)
Regulation Number
866.3165 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Candida Detection System is an antigen identification device for Candida albicans, classified under microbiology specialty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device is supplied by Ramco Laboratories, Inc., located in Mchenry, Illinois, and holds FDA 510(k) authorization under K number K823016. It is regulated as a Class II medical device with product code LHK and is intended for use in microbiology laboratory settings.

Frequently asked questions

What is the Candida Detection System used for?

The Candida Detection System is an antigen identification device designed to detect Candida albicans in microbiology laboratory settings, as specified in its device description and classification under microbiology specialty.

How is the Candida Detection System supplied and by whom?

The device is supplied by Ramco Laboratories, Inc., located at 803 N. Front St. Suite 3, Mchenry, Illinois 60050, United States, as stated in the manufacturer and address fields of the device data.

Is the Candida Detection System a single-use or reusable device?

The device data does not specify whether the Candida Detection System is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.

What regulatory pathway was used for the Candida Detection System?

The Candida Detection System was cleared through the traditional 510(k) pathway as a substantially equivalent device, with authorization under K number K823016, as indicated in the DESCRIPTION and AUTHORIZATIONS fields.

What is the device classification and product code for the Candida Detection System?

The Candida Detection System is regulated as a Class II medical device with product code LHK, as confirmed in the SPECIFICATIONS section under product_code and device_class=2.

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: Ramco Laboratories CAND-TEC Candida Detection System (11146), Ramco Laboratories CAND-TEC Candida Detection System Diagnostic Test ..., Candida Detection System 510 (k) FDA Premarket Notification K823016 ..., Cand-Tec CO3/5 Candida Detection GUDID Device - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ramco Laboratories, Inc.

Sources (1)

  • FDA 510(k) K823016 24 fields · synced Oct 1, 2026