Skip to content

Seralyzer Aris Carbamazepine Strips/Modu/Cali/Cont

by Miles Laboratories, Inc.

510(k) K863842

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 NumberK863842 Date14 Jan 1987ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Seralyser Aris Carbamazepine Strips/Modu/Cali/Cont is an enzyme immunoassay for carbamazepine, classified under product code KLT and regulation number 862.3645. It is an in vitro diagnostic test used in clinical toxicology laboratories to quantitatively measure carbamazepine serum levels.

It supports therapeutic drug monitoring for patients receiving carbamazepine, an antiepileptic and mood-stabilizing medication. The device received FDA 510(k) clearance (K863842) as substantially equivalent and is classified as FDA Class II, indicating moderate risk requiring premarket notification.

Other devices from Miles Laboratories, Inc.

See all devices from Miles Laboratories, Inc. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Seralyser Aris Carbamazepine Strips/Modu/Cali/Cont used for?

    It is an in vitro diagnostic test used in clinical toxicology laboratories to quantitatively measure carbamazepine serum levels, supporting therapeutic drug monitoring for patients receiving carbamazepine, an antiepileptic and mood-stabilizing medication.

  • How is the Seralyser Aris Carbamazepine Strips/Modu/Cali/Cont supplied?

    The device is supplied as strips, modules, calibrators, and controls as indicated in its name, though specific quantities or packaging details are not provided in the device data.

  • Is the Seralyser Aris Carbamazepine Strips/Modu/Cali/Cont sterile or single-use?

    The device data does not specify sterility or single-use/reuse status; as an in vitro diagnostic enzyme immunoassay, it is intended for laboratory use with appropriate handling per manufacturer instructions.

  • What regulatory pathway was used for the Seralyser Aris Carbamazepine Strips/Modu/Cali/Cont?

    It received FDA 510(k) clearance (K863842) as substantially equivalent and is classified as FDA Class II, indicating moderate risk requiring premarket notification under regulation number 862.3645.