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Emit Qst Carbamazepine Assay

by Syva Co. 510(k)

Active United States

510(k) K853835

Overview

The Emit Qst Carbamazepine Assay is an enzyme immunoassay for carbamazepine, classified as a Class II device. It is used for clinical toxicology purposes. The device is substantially equivalent to other devices on the market.

The Emit Qst Carbamazepine Assay is supplied with a product code of KLT and has been cleared by the FDA with the k number K853835. The device is intended for use in a clinical setting and is regulated under the regulation number 862.3645. The manufacturer, Syva Co, is located in Palo Alto, US.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853835 Date1 Oct 1985ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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

Other devices from Syva Co.

See all devices from Syva Co. →

Questions

  • What is the Emit Qst Carbamazepine Assay used for?

    The Emit Qst Carbamazepine Assay is used for clinical toxicology purposes, specifically to measure carbamazepine levels.

  • Is the Emit Qst Carbamazepine Assay cleared by the FDA?

    Yes, the Emit Qst Carbamazepine Assay has been cleared by the FDA with the k number K853835, indicating it has met the necessary regulatory requirements.

  • What type of device is the Emit Qst Carbamazepine Assay?

    The Emit Qst Carbamazepine Assay is classified as a Class II device and is an enzyme immunoassay.