Theophylline Fpia Reagent Set

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K870952 ↗

FDA Product Code

KLS

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 Sigma Diagnostics, Inc. →

• What is the primary clinical use of the Theophylline FPIA Reagent Set?

  This device is used for the quantitative determination of theophylline levels in human serum or plasma samples. It is specifically designed to assist clinicians in the ongoing monitoring of theophylline concentrations in patients.

• What regulatory classification does this device hold?

  The Theophylline FPIA Reagent Set is classified under regulation number 862.3880 within the clinical toxicology medical specialty. It has received FDA 510(k) clearance under submission number K870952.

• Who is the manufacturer of this reagent set?

  This device is manufactured by Sigma Diagnostics, Inc., located in St. Louis, Missouri. The company is the applicant of record for the FDA 510(k) clearance associated with this product.