Fibri-Prest Automate HA34

• • Ongoing Z-2476-2025 FDA Class II ·initiated 21 Jul 2025

  Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

510(k) Number

K840211 ↗

FDA Product Code

KQJ

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Streptex Acid Extraction Kit

  Class I

  FDA 510(k) K910797 Active Cleared 29 Mar 1991

• Wellcogen H. Influenzal ZL21

  Class I

  FDA 510(k) K833077 Active Cleared 10 Jan 1984

• Wellcogen Bacterial Antigen Kit

  Class II

  FDA 510(k) K854852 Active Cleared 4 Feb 1986

• Streptex Direct a ZL14

  Class I

  FDA 510(k) K842827 Active Cleared 16 Aug 1984

• Diacrom * Atiii

  Class II

  FDA 510(k) K832592 Active Cleared 29 Sep 1983

• Diacrom * Factor X Kit HA31

  Class II

  FDA 510(k) K832372 Active Cleared 29 Sep 1983

See all devices from Wellcome Diagnostics →