ICS Theophylline Reagents

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K850856 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

• Beckman Urine Protein Calibrator (Ucal)

  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

  Class II

  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

See all devices from Beckman Instruments, Inc. →

• What is the intended use of ICS Theophylline Reagents?

  ICS Theophylline Reagents are intended for the quantitative determination of theophylline in human serum or plasma, used in clinical toxicology settings to monitor therapeutic drug levels.

• How are ICS Theophylline Reagents supplied and what is their format?

  The reagents are supplied by Beckman Instruments, Inc. as an enzyme immunoassay device, though the provided data does not specify whether they are liquid, lyophilized, kit-based, or single-use.

• What regulatory pathway was used for ICS Theophylline Reagents and when was it cleared?

  ICS Theophylline Reagents were cleared via the traditional 510(k) pathway under submission K850856, with a decision date of March 29, 1985, and are classified as substantially equivalent to a predicate device.