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

Test, Fibrinogen

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

GIS is the FDA product code for Test, Fibrinogen, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIS
Device name
Test, Fibrinogen
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
13
Ingested recalls
0

Clearances, product code GIS

By decision year
13 clearances under product code GIS with a decision year between 1978 and 2016, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GIS by decision year
YearClearances
19781
19882
19913
19921
19931
19941
19961
19991
20041
20161

Applicants with the most clearances

Product code GIS
Applicants holding the most 510(k) clearances under product code GIS
ApplicantClearances
Bio/Data Corp.1
Biomerieux Vitek, Inc.1
Diagnostic Specialties1
Diatech, Inc.1
Diazyme Laboratories, Inc.1
Haemachem, Inc.1
Instrumentation Laboratory Co.1
Kamiya Biomedical Company, LLC1
Ortho Diagnostic Systems, Inc.1
Pacific Hemostasis1

Companies listing this code with FDA

Companies whose registered establishments list this code