GIS · Class II · 21 CFR 864.7340

FDA Product Code GIS: Test, Fibrinogen

Leading manufacturers include Diazyme Laboratories.

1
Total
1
Cleared
422d
Avg days
2016
Since

List of Test, Fibrinogen devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Test, Fibrinogen devices (product code GIS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →