Actichrome Heparin (Anti-Fxa), Model 832

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K013318 ↗

FDA Product Code

KFF

Device Class

Class II

Regulation

21 CFR Part 864.7525

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Diagnostica, Inc. →

• What is the ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 used for?

  This device is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma by measuring the inhibition of factor Xa (fXa) activity by the various heparins, as stated in the device description.

• Is the ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 supplied as sterile or single-use?

  The device is not indicated as sterile, single-use, or reusable based on the provided data, and it is intended for in vitro diagnostic use in clinical laboratory settings.

• What regulatory pathway was used for the ACTICHROME HEPARIN (ANTI-FXA), MODEL 832?

  The assay is regulated as a Class II medical device under FDA 510(k) clearance K013318, with a traditional clearance type and a substantially equivalent decision, as specified in the device data.