ACA Fibrinogen Calibrator

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

510(k) Number

K812628 ↗

FDA Product Code

GFX

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What is the ACA Fibrinogen Calibrator used for?

  The ACA Fibrinogen Calibrator is a fibrinogen standard specifically designed for calibrating laboratory equipment to ensure accurate reference values for fibrinogen testing in clinical laboratory settings.

• How is the ACA Fibrinogen Calibrator supplied?

  The device is supplied by E.I. Dupont DE Nemours & Co., Inc. and is classified as a Class II medical device with special controls, requiring appropriate storage conditions as specified by the manufacturer.

• What is the regulatory status of the ACA Fibrinogen Calibrator?

  The device received FDA 510(k) clearance on November 24, 1981, with product code GFX, and is intended for laboratory use only.

• Is the ACA Fibrinogen Calibrator single-use or reusable?

  The device information does not specify whether it is single-use or reusable, so users should follow the manufacturer's instructions regarding usage and disposal.