Hepcol System B-10 & B-10-P

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K830665 ↗

FDA Product Code

JOX

Device Class

Class II

Regulation

21 CFR Part 864.5680

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hepcon/System Rc-10

  Class II

  FDA 510(k) K800161 Active Cleared 19 Mar 1980

• Hemotec Citrated Whole Blood Coagulation Controls

  Class II

  FDA 510(k) K854376 Active Cleared 4 Dec 1985

• Hemotec Act I System

  Class II

  FDA 510(k) K843459 Active Cleared 12 Dec 1984

• Additional Hemotec Hepcon/Sys B-10 Coagulation Car

  Class II

  FDA 510(k) K853789 Active Cleared 4 Oct 1985

• Clottrac(Tm) Ibex Heparinase Hr Act Cart./Control

  Class II

  FDA 510(k) K902081 Active Cleared 3 Jul 1990

• Hepcon(R) Cv Whole Blood Coagulation Controls

  Class II

  FDA 510(k) K894466 Active Cleared 5 Sep 1989

See all devices from Hemotec, Inc. →