Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # LKCB1, LKCB5 & L2KCB2, L2KCB6

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

510(k) Number

K000007 ↗

FDA Product Code

KLT

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Immulite 2000 3RD Generation Psa

  Class II

  FDA 510(k) K974842 Active Cleared 21 Apr 1998

• Immulite Turbo Ck-Mb, Models LSKCP1, LSKCP5

  Class II

  FDA 510(k) K991797 Active Cleared 9 Jun 1999

• Coat-A-Count T4 Ria Kit

  Class II

  FDA 510(k) K811315 Active Cleared 27 May 1981

• Immulite(R) Tbg

  Class I

  FDA 510(k) K950072 Active Cleared 3 Apr 1995

• Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

  Class II

  FDA 510(k) K012301 Active Cleared 19 Sep 2001

• Coat-A-Count Direct Androstenedione

  Class I

  FDA 510(k) K954755 Active Cleared 29 Nov 1995

See all devices from Diagnostic Products Corp. →

• What is the Immulite Carbamazepine device used for?

  The Immulite Carbamazepine is an enzyme immunoassay device used for the quantitative determination of carbamazepine in human serum and plasma. It is designed to assist in monitoring therapeutic drug levels for patients treated with carbamazepine.

• How is the Immulite Carbamazepine supplied and what are its catalog numbers?

  The device is supplied as a single-use product and is intended for laboratory use only. It is available in catalog numbers LKCB1, LKCB5, L2KCB2, and L2KCB6.

• What is the regulatory status of the Immulite Carbamazepine device?

  The device is regulated under FDA 510K clearance with device class II and product code KLT. It was received by the FDA on January 3, 2000, and cleared on February 28, 2000, with decision code SESE indicating substantial equivalence.

• What is the manufacturer of the Immulite Carbamazepine device?

  The Immulite Carbamazepine device is manufactured by Diagnostic Products Corp., located at 5700 W. 96th St., Los Angeles, CA 90045.