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Nrbc-Chex For Lh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060083

by Streck

Identifiers

510(k) Number
K060083 FDA 510(k)
FDA Product Code
GJR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.8625 FDA 510(k)
Regulation Number
864.8625 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

NRBC-CHEX FOR LH is a control, red-cell device classified under product code GJR and regulation number 864.8625. It is intended for use in hematology as a substantially equivalent device cleared via the traditional 510(k) pathway.

The device was submitted by Streck of La Vista, Nebraska, and received FDA clearance on February 9, 2006, under k-number K060083. It is supplied as a non-sterile, in vitro diagnostic control for red-cell analysis, with no indications of sterility, single-use status, or MRI safety specified in the provided data.

Frequently asked questions

What is the NRBC-CHEX FOR LH device used for?

NRBC-CHEX FOR LH is a control device for red-cell analysis used in hematology laboratories. It serves as an in vitro diagnostic control for quality assurance in red cell testing procedures.

How is the NRBC-CHEX FOR LH device supplied?

The device is supplied as a non-sterile control for red-cell analysis. The data does not specify sterility status, single-use designation, or MRI safety characteristics.

What is the regulatory status of the NRBC-CHEX FOR LH device?

NRBC-CHEX FOR LH received FDA clearance on February 9, 2006, under k-number K060083. It is classified as substantially equivalent via the traditional 510(k) pathway.

What are the specifications of the NRBC-CHEX FOR LH device?

The device is classified under product code GJR and regulation number 864.8625. It is a Class II device with medical specialty in Hematology, manufactured by Streck in La Vista, Nebraska.

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: K060083 FDA 510 (k) - NRBC-CHEX FOR LH | Streck, Streck nRBC-Chex LH Instructions: AI Chat & PDF Access | Manualzz, NRBC-CHEX FOR LH 510 (k) K060083 - FDA.report, 510 (k) K060083 — NRBC-CHEX FOR LH — RegDataLab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA 510(k) K060083 24 fields · synced Sep 19, 2026