Fpr Carbamazepine Kit

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K894519 ↗

FDA Product Code

KLT

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Fpr Digoxin Calibrator Kit

  Class II

  FDA 510(k) K894522 Active Cleared 25 Sep 1989

• Fpr Gentamicin Calibrator Kit

  Class I

  FDA 510(k) K894524 Active Cleared 28 Sep 1989

• Fpr Digoxin Kit

  Class II

  FDA 510(k) K894521 Active Cleared 25 Sep 1989

• Fpr Theophylline Kit

  Class II

  FDA 510(k) K894529 Active Cleared 15 Sep 1989

• Fpr Theophylline Calibrator Kit

  Class II

  FDA 510(k) K894530 Active Cleared 18 Sep 1989

• Fpr Amikacin Calibrator Kit

  Class I

  FDA 510(k) K894518 Active Cleared 28 Sep 1989

See all devices from Colony Laboratories, Inc. →