Easy-Test Hemoglobin (Hgb) Item #16685

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K872653 ↗

FDA Product Code

KHG

Device Class

Class II

Regulation

21 CFR Part 864.7500

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical use for the Easy-Test Hemoglobin Item #16685?

  This device is designed to measure the hemoglobin content of whole blood samples. It is specifically intended for use in the detection of anemia.

• What components are included in this hemoglobin assay system?

  The system consists of the necessary reagents, calibrators, and controls, along with photometric or spectrophotometric instrumentation required to perform the hemoglobin measurement.

• Is this device considered an automated hemoglobin system?

  No, this specific device category and the Easy-Test Hemoglobin Item #16685 do not include automated hemoglobin systems.

• What is the regulatory status of this device?

  The Easy-Test Hemoglobin Item #16685 is a class 2 medical device that has received FDA 510(k) clearance under K872653, as it was determined to be substantially equivalent to existing predicate devices.