Edl Abnormal Coagulation Control

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K891175 ↗

FDA Product Code

GGL

FDA applicant

Elite Diagnostic , Ltd.

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Edl Global Activated Partial Thromboplastin Time

  Class II

  FDA 510(k) K890859 Active Cleared 21 Apr 1989

• EDL Normal Coagulation Control

  Class II

  FDA 510(k) K891179 Active Cleared 10 Apr 1989

• Edl Activated Partial Thromboplastin Time Reagent

  Class II

  FDA 510(k) K890619 Active Cleared 15 Mar 1989

• Edl One-Stage Prothrombin Time Reagent

  Class II

  FDA 510(k) K891370 Active Cleared 21 Apr 1989