Hemotec Citrated Whole Blood Coagulation Controls

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K854376 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hepcol System B-10 & B-10-P

  Class II

  FDA 510(k) K830665 Active Cleared 8 Jun 1983

• Hepcon/System Rc-10

  Class II

  FDA 510(k) K800161 Active Cleared 19 Mar 1980

• 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. →

• What is the primary purpose of the Hemotec Citrated Whole Blood Coagulation Controls in a clinical laboratory setting?

  The Hemotec Citrated Whole Blood Coagulation Controls are designed to ensure the accuracy and reliability of coagulation studies and factor assays in hematology diagnostics. They are used alongside automated or semiautomated coagulation testing instruments to verify test performance, helping laboratories maintain precise results for patient evaluations.

• Are these controls intended for reuse, or are they meant for single-use only?

  These controls are explicitly intended for single-use in laboratory settings. Each lot is individually packaged, which aligns with standard practices for maintaining sterility and consistency in diagnostic testing.

• How are these controls supplied, and what should I consider when storing them?

  The controls are supplied as citrated whole blood, packaged individually per lot. Since they are for single-use, proper storage involves keeping them in a clean, dry environment away from extreme temperatures or direct light until use. Always follow manufacturer guidelines for specific storage conditions to preserve stability and integrity.

• What regulatory pathway was used for the FDA clearance of these coagulation controls?

  The Hemotec Citrated Whole Blood Coagulation Controls received FDA clearance through a Traditional 510(k) process (K854376), with a decision of Substantially Equivalent. The device falls under the Hematology advisory committee (HE) and is classified as a Class II medical device under FDA regulation 864.5425. No third-party review was required for this submission.