Turbox Fibrinogen

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K884179 ↗

FDA Product Code

KQJ

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Clearblue Easy

  Class II

  FDA 510(k) K911566 Active Cleared 6 May 1991

• Immunoglobulins G

  Class II

  FDA 510(k) K873870 Active Cleared 13 Oct 1987

• Cefepine Antimicrobial Susceptibility Test Disc

  Class II

  FDA 510(k) K964495 Active Cleared 7 Feb 1997

• Clearblue Easy Earliest Results Pregnancy Test

  Class II

  FDA 510(k) K040341 Active Cleared 8 Mar 2004

• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

  Class II

  FDA 510(k) K913305 Active Cleared 22 Nov 1991

• E.P.T. Certainty Pregnancy Test

  Class II

  FDA 510(k) K050930 Active Cleared 12 May 2005

See all devices from Unipath, Ltd. →

• What clinical conditions can the Turbox Fibrinogen help diagnose or monitor, and how does it do this?

  The Turbox Fibrinogen is designed for quantitative measurement of fibrinogen levels in blood, which is essential for diagnosing and monitoring bleeding disorders or conditions involving thromboembolic risks. By providing precise fibrinogen concentration readings, it supports clinical decisions related to coagulation studies in hematology, helping assess a patient’s risk for abnormal bleeding or clotting.

• Is the Turbox Fibrinogen a single-use device, or can it be reused in a clinical setting?

  The Turbox Fibrinogen is explicitly described as a reusable diagnostic system for clinical hematology laboratories. While the device itself is not single-use, it operates under sterile conditions during use, adhering to standard laboratory protocols for coagulation analyzers.

• What storage and handling requirements should be followed for the Turbox Fibrinogen?

  The Turbox Fibrinogen follows standard laboratory protocols for coagulation analyzers, though no specific storage instructions are detailed in the regulatory data. It is important to maintain the device in a clean, controlled environment to ensure accurate and reliable fibrinogen measurements, as with any reusable diagnostic system.

• What regulatory pathway was followed for the Turbox Fibrinogen’s clearance, and which advisory committee was involved?

  The Turbox Fibrinogen received FDA clearance through a Traditional 510(k) pathway (K884179) and was reviewed by the Hematology (HE) Advisory Committee. The decision was based on substantial equivalence (SESE) to a predicate device, placing it under FDA Class II regulation (21 CFR 864.7340).