Phase II Theophylline Radioimmunoassay

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

510(k) Number

K833789 ↗

FDA Product Code

LCA

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical & Scientific Designs, Inc. →

• What is the Phase II Theophylline Radioimmunoassay used for?

  The Phase II Theophylline Radioimmunoassay is a Class II medical device used for the quantitative determination of theophylline levels in human serum or plasma. Theophylline is a medication commonly used to treat respiratory diseases such as asthma and COPD.

• How is the Phase II Theophylline Radioimmunoassay supplied?

  The device is supplied as a kit and is intended for single-use in clinical laboratory settings. It requires storage according to the manufacturer's instructions and is not MRI compatible.

• What is the regulatory status of the Phase II Theophylline Radioimmunoassay?

  The device received FDA 510(k) clearance with K number K833789 and is classified under product code LCA, regulated under 21 CFR 862.3880. It was determined to be substantially equivalent to other devices on the market.

• What are the specifications of the Phase II Theophylline Radioimmunoassay?

  The device is a radioimmunoassay kit designed for quantitative determination of theophylline in human serum or plasma. It is a single-use device intended for clinical laboratory settings and requires proper storage as per manufacturer instructions.