Acs Phenytoin Assay

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

510(k) Number

K955873 ↗

FDA Product Code

LGR

Device Class

Class II

Regulation

21 CFR Part 862.3350

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →

• What is the ACS Phenytoin Assay used for?

  The ACS Phenytoin Assay is a fluorescence polarization immunoassay device used to measure diphenylhydantoin levels in human specimens. It helps in diagnosing and treating diphenylhydantoin overdose and monitoring drug levels to ensure appropriate therapy for epilepsy patients.

• How is the ACS Phenytoin Assay supplied?

  The ACS Phenytoin Assay is supplied by Ciba Corning Diagnostics Corp. It is a class 2 device regulated under product code LGR and has been granted FDA 510K clearance with number K955873. The device is used in clinical toxicology applications.

• Is the ACS Phenytoin Assay sterile and single-use or reusable?

  The device data does not specify sterility or single-use/reuse information. The ACS Phenytoin Assay is a fluorescence polarization immunoassay system designed for measuring diphenylhydantoin in human specimens, but specific details about sterility or usage limitations are not provided in the available information.

• What regulatory approvals does the ACS Phenytoin Assay have?

  The ACS Phenytoin Assay has been granted FDA 510K clearance with clearance number K955873. It is classified as a class 2 device under product code LGR and is regulated for use in clinical toxicology. The device received its clearance on March 11, 1996, after being received by the FDA on December 26, 1995.