COBAS-FP Quinidine Reagents and Calibrators

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

510(k) Number

K941440 ↗

FDA Product Code

LBZ

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 COBAS-FP Quinidine Reagents and Calibrators used for?

  The COBAS-FP Quinidine Reagents and Calibrators is an enzyme immunoassay device designed to detect quinidine levels in clinical specimens, used with the COBAS-FP analyzer for in vitro diagnostic testing in clinical toxicology.

• How is the COBAS-FP Quinidine Reagents and Calibrators supplied?

  The device is supplied as reagents and calibrators for in vitro diagnostic use, specifically formulated for use with the COBAS-FP analyzer to measure quinidine in clinical specimens.

• What regulatory clearance does the COBAS-FP Quinidine Reagents and Calibrators have?

  The device received FDA 510(k) clearance (K941440) on July 6, 1994, as substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation number 862.3320.