Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model 7A409UL

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K002974 ↗

FDA Product Code

LDP

Models / Variants

Emit Tox Acetaminophen Assay, Model 7A319UL

Emit Tox Ecetaminophen Calibrators, Model 7A409UL

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Apolipoprotein Control Serum Chd, Model Ouph

  Class I

  FDA 510(k) K993310 Active Cleared 30 Nov 1999

• Dade Tru-Liquid Cardiac Control

  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

• Behring Coagulation System, Model BCS

  Class II

  FDA 510(k) K002080 Active Cleared 16 Nov 2000

• Modification to N Protein Standard Sl

  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

See all devices from Dade Behring, Inc. →