ACE Carbamazepine Reagent/AED Calibrators

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

510(k) Number

K973535 ↗

FDA Product Code

KLT

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Ace Primidone Reagent, Aed Calibrators

  Class II

  FDA 510(k) K973582 Active Cleared 12 Nov 1997

• Triglycerides Reagent

  Class I

  FDA 510(k) K954187 Active Cleared 23 Oct 1995

• Ace Hdl-C Reagent

  Class I

  FDA 510(k) K971526 Active Cleared 21 May 1997

• Ace Clinical Chemistry System

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  FDA 510(k) K941489 Active Cleared 18 Jul 1994

• Ace Iron Reagent

  Class I

  FDA 510(k) K944911 Active Cleared 10 Feb 1995

• Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C Controls

  Class I

  FDA 510(k) K991733 Active Cleared 13 Jul 1999

See all devices from Schiapparelli Biosystems, Inc. →

• What is the ACE Carbamazepine Reagent used for?

  The ACE Carbamazepine Reagent is an enzyme immunoassay designed for the quantitative measurement of carbamazepine levels in human serum. It operates through competitive binding between carbamazepine in patient samples and G6PDH-labeled drug for specific antibody binding sites.

• How is the ACE Carbamazepine Reagent supplied?

  This device is supplied as a reagent/calibrator system intended for laboratory use. The data does not specify whether it is single-use or reusable, only that it is manufactured by Schiapparelli Biosystems, Inc.

• What is the regulatory status of the ACE Carbamazepine Reagent?

  The ACE Carbamazepine Reagent is a Class II device cleared by the FDA under 510(k) K973535 with product code KLT and regulation number 862.3645. It was determined to be substantially equivalent through the traditional clearance process.

• What laboratory applications is this device suitable for?

  This device is intended for laboratory use in the quantitative measurement of carbamazepine in human serum. It is part of the Clinical Toxicology medical specialty category, suggesting applications in therapeutic drug monitoring and toxicology testing.