Documentr Ammonia/Ethanolcalibrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K944639 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Document Enzyme

  Class I

  FDA 510(k) K932458 Active Cleared 29 Jun 1993

• Document Molecular Pathology Chlamydia Trachomatis Control

  Class I

  FDA 510(k) K972904 Active Cleared 20 Feb 1998

• Document Enzyme Linearity Test Sets

  Class I

  FDA 510(k) K861506 Active Cleared 13 Jun 1986

• Document R Ammonia / Ethanol Calibration Verification Rest Set

  Class I

  FDA 510(k) K944338 Active Cleared 15 Nov 1994

• Document(Tm) Triglyceride Linearity Test Set

  Class I

  FDA 510(k) K893140 Active Cleared 23 Jun 1989

• Document Chem I Calibration Verification Test Set

  Class I

  FDA 510(k) K923795 Active Cleared 5 Nov 1992

See all devices from Casco Standards →