Modification to Emit 2000 Theophylline Assay, Model Osr 4P229

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K011166 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Syva Emit 2000 Thyroxine Assay, Calibrators

  Class II

  FDA 510(k) K000600 Active Cleared 27 Mar 2000

• Emit II Plus Opiate Assay, Model OSR9B229

  Class II

  FDA 510(k) K011289 Active Cleared 15 May 2001

• Emit 2000 Digoxin Assay, Model OSR4H229

  Class II

  FDA 510(k) K011920 Active Cleared 2 Jul 2001

• Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229

  Unclassified

  FDA 510(k) K011161 Active Cleared 15 May 2001

• Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229

  Class II

  FDA 510(k) K011163 Active Cleared 10 May 2001

• Emit II Plus Cannabinoid Assay, Model OSR9N229

  Class II

  FDA 510(k) K011300 Active Cleared 17 May 2001

See all devices from Syva Co., Dade Behring, Inc. →