CEDIA N-Acetylprocainamide Assay

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K963306 ↗

FDA Product Code

LAR

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the CEDIA N-Acetylprocainamide Assay used for?

  This in vitro diagnostic device is designed for the quantitation of N-Acetylprocainamide in human serum or plasma, specifically intended for use in clinical toxicology settings to monitor drug levels.

• How is the CEDIA N-Acetylprocainamide Assay supplied?

  The device is supplied as a Class II medical device with special controls. It is manufactured by Boehringer Mannheim Corp. in Concord, CA, and is not specified as single-use or reusable in the provided information.

• What is the regulatory status of the CEDIA N-Acetylprocainamide Assay?

  This device was cleared by the FDA on October 29, 1996 under 510(k) number K963306, classified as substantially equivalent to predicate devices for the quantitation of N-Acetylprocainamide in human serum or plasma.

• What is the product code and classification of this assay?

  The CEDIA N-Acetylprocainamide Assay operates under product code LAR and is classified as an Enzyme Immunoassay for Procainamide, with FDA clearance indicating it meets safety and effectiveness requirements for its intended use.