Fluorescence Polarization Immunoassay Carbamazepine

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K944063 ↗

FDA Product Code

LGI

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K932980 Active Cleared 18 Oct 1993

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  Class II

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  Class II

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  Class II

  FDA 510(k) K954839 Active Cleared 5 Jan 1996

• Ethanol Controls, Urine, Levels 1, II, and III

  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

See all devices from Sigma Diagnostics, Inc. →