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Quanticoat 125 I-Theophylline Radioimmunoassay

by Kallestad Laboratories, Inc.

510(k) K821862

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821862 Date6 Jul 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Quanticoat 125 I-Theophylline Radioimm.
510(k) Number
FDA Product Code
LCA
Device Class
Class II
Regulation
21 CFR Part 862.3880
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Quanticoat 125 I-Theophylline Radioimmunoassay is a diagnostic in vitro device used for measuring theophylline levels in biological samples. Classified as a radioimmunoassay under the FDA’s regulation number 862.3880, it employs radiolabeled iodine-125 to quantify theophylline concentrations, aiding in clinical toxicology assessments.

This device is supplied as a single-use diagnostic kit and requires no sterilization beyond manufacturer-provided packaging. It is intended for use in laboratory settings, adhering to Class II regulatory standards under the FDA’s 510(k) clearance (K821862). Storage conditions and handling must comply with radioactive material regulations, and its use is governed by the product code LCA and advisory committee review for clinical toxicology applications.

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