510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GFXClass II

Fibrinogen Standard

21 CFR 864.7340 / Hematology
FDA source (opens on fda.gov)

GFX is the FDA product code for Fibrinogen Standard, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GFX
Device name
Fibrinogen Standard
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GFX

By decision year
3 clearances under product code GFX with a decision year between 1981 and 2007, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GFX by decision year
YearClearances
19811
20001
20071

Applicants with the most clearances

Product code GFX
Applicants holding the most 510(k) clearances under product code GFX
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
E.I. Dupont de Nemours & Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code