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

Fibrinogen Determination Standards And Controls

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

GFK is the FDA product code for Fibrinogen Determination Standards And Controls, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GFK
Device name
Fibrinogen Determination Standards And Controls
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code GFK

By decision year
1 clearance under product code GFK with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GFK by decision year
YearClearances
19831

Applicants with the most clearances

Product code GFK
Applicants holding the most 510(k) clearances under product code GFK
ApplicantClearances
Fujisawa Electronics Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code