Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test

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

510(k) Number

K993519 ↗

FDA Product Code

JOX

Models / Variants

2000

Rapidpoint Coag Heparin Titration Test

Rapidpoint Coag Protamine Response Test

Device Class

Class II

Regulation

21 CFR Part 864.5680

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• (Tas) Low Range Heparin Management Card Rapidpoint

  Class II

  FDA 510(k) K994194 Active Cleared 28 Mar 2000

• Enoxaparin Test Card

  Class II

  FDA 510(k) K013305 Active Cleared 23 Aug 2002

• Heparin Management Test Card; Hmt Card

  Class II

  FDA 510(k) K943283 Active Cleared 10 May 1995

• Thrombolytic Assessment System Prothrombin Time Test Controls

  Class II

  FDA 510(k) K961814 Active Cleared 13 Aug 1996

• Prothrombin Time Test Card

  Class II

  FDA 510(k) K954625 Active Cleared 11 Mar 1996

• Tas Analyzer, Model 1009

  Class II

  FDA 510(k) K990566 Active Cleared 14 May 1999

See all devices from Cardiovascular Diagnostics, Inc. →