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Determination Of Carbamazepine

by Clinical Data, Inc.

510(k) K860047

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 NumberK860047 Date22 Jan 1986ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
KLT
Device Class
Class II
Regulation
21 CFR Part 862.3645
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Determination of Carbamazepine is an enzyme immunoassay device used for the clinical toxicology assessment of carbamazepine levels. It functions as an in vitro diagnostic tool to measure the concentration of this medication in patient samples.

This device is regulated under FDA 510(k) clearance K860047. It is intended for use in a clinical laboratory setting for the quantitative analysis of carbamazepine.

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