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

Plasma, Fibrinogen Control

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

GIL is the FDA product code for Plasma, Fibrinogen Control, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIL
Device name
Plasma, Fibrinogen Control
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
8
Ingested recalls
0

Clearances, product code GIL

By decision year
8 clearances under product code GIL with a decision year between 1983 and 1996, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GIL by decision year
YearClearances
19831
19921
19941
19954
19961

Applicants with the most clearances

Product code GIL
Applicants holding the most 510(k) clearances under product code GIL
ApplicantClearances
Clinical Controls, Inc.3
Behring Diagnostics, Inc.2
More Diagnostics Inc.1
Sigma Diagnostics, Inc.1
Warner-Lambert Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code