Product code GFX— Hematology

FIBRINOGEN CALIBRATOR KIT

Classification name: Fibrinogen Standard
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Total cleared: 3
First cleared: 1981-11-24
Most recent: 2007-09-19

Market context for product code GFX

FDA has cleared 3 devices under product code GFX between 1981 and 2007, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20071 clearance
20001 clearance
19811 clearance

Top applicants under product code GFX

Dade Behring, Inc.2 clearances
E.I. Dupont DE Nemours & Co., Inc.1 clearance

Recent clearances under product code GFX

K072304 — FIBRINOGEN CALIBRATOR KITDade Behring, Inc.·2007-09-19
K994341 — FIBRINOGEN CALIBRATOR KITDade Behring, Inc.·2000-03-03
K812628 — ACA FIBRINOGEN CALIBRATORE.I. Dupont DE Nemours & Co., Inc.·1981-11-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.