Glycohemoglobin-Skreen Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780819 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Glycohemoglobin-Skreen Test Kit used for?

  The Glycohemoglobin-Skreen Test Kit is an assay designed to measure levels of glycosylated hemoglobin in blood samples. It is used in hematology to assess long-term blood glucose control, providing diagnostic information for conditions such as diabetes.

• How is the Glycohemoglobin-Skreen Test Kit supplied and where is it intended for use?

  The device is supplied as a test kit and is intended for use in clinical laboratory settings. It is distributed in the United States by Eppendorf-Brinkmann, Inc. for professional diagnostic testing of blood samples.

• Is the Glycohemoglobin-Skreen Test Kit a single-use or reusable device?

  The Glycohemoglobin-Skreen Test Kit is supplied as a test kit, which implies it contains reagents and components for performing the assay. Based on its description as an in vitro diagnostic test kit, it is intended for single-use per test, though the kit may allow multiple tests depending on the number of tests included.

• What regulatory pathway was used for the Glycohemoglobin-Skreen Test Kit and what is its classification?

  The device received FDA 510(k) clearance under submission K780819 on November 7, 1978. It is classified as a Class II medical device under regulation number 864.7470, with product code LCP, and was found substantially equivalent to a predicate device.

• What are the storage and handling requirements for the Glycohemoglobin-Skreen Test Kit?

  The device data does not specify storage conditions, temperature requirements, or shelf life for the Glycohemoglobin-Skreen Test Kit. Users should consult the manufacturer’s labeling or instructions for use for proper storage and handling guidance.