GFX · Fibrinogen Standard
Hematology · 21 CFR 864.7340 · Class 2
Overview
| Product Code | GFX |
|---|---|
| Device Name | Fibrinogen Standard |
| Regulation | 21 CFR 864.7340 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Classification Rationale
Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072304 | FIBRINOGEN CALIBRATOR KIT | Dade Behring, Inc. | Sep 19, 2007 | SESE |
| K994341 | FIBRINOGEN CALIBRATOR KIT | Dade Behring, Inc. | Mar 3, 2000 | SESE |
| K812628 | ACA FIBRINOGEN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Nov 24, 1981 | SESE |
Top Applicants
- Dade Behring, Inc. — 2 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
