EMDS Antiepileptic Drug Calibrators Item #67630/95

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K862403 ↗

FDA Product Code

DKB

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What are EMDS Antiepileptic Drug Calibrators used for?

  These calibrators are designed to assist in the calibration of laboratory equipment specifically for antiepileptic drug testing in clinical toxicology settings.

• How are the EMDS Antiepileptic Drug Calibrators supplied?

  The calibrators are supplied by Diagnostic Systems and are manufactured in Gibbstown, NJ. They are authorized under FDA 510K clearance with device class 2.

• What is the regulatory status of these calibrators?

  The EMDS Antiepileptic Drug Calibrators are authorized under FDA 510K clearance with device class 2, regulated under product code DKB and regulation number 862.3200.

• Are these calibrators single-use or reusable?

  The device data does not specify whether these calibrators are single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.