NSI Calibrator Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K800588 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the NSI Calibrator Set used for?

  The NSI Calibrator Set is designed for calibration purposes in clinical chemistry testing. It provides standardized reference materials to ensure the accuracy and reliability of laboratory equipment, helping maintain precise test results in clinical settings.

• How is the NSI Calibrator Set supplied?

  The NSI Calibrator Set is supplied by Nobel Scientific Industries, Inc. It is authorized under FDA 510(k) clearance K800588 with product code JIS and is regulated under 21 CFR 862.1150, intended specifically for clinical chemistry laboratory environments.

• What is the regulatory status of the NSI Calibrator Set?

  The NSI Calibrator Set has received FDA 510(k) clearance K800588 with product code JIS. It is classified as substantially equivalent and regulated under 21 CFR 862.1150, with review by the Clinical Chemistry advisory committee.

• Is the NSI Calibrator Set reusable or single-use?

  The device data does not specify whether the NSI Calibrator Set is designed for single-use or multiple uses. For proper handling and reuse instructions, users should consult the manufacturer's documentation or contact Nobel Scientific Industries, Inc. directly.