GIL · Plasma, Fibrinogen Control
Hematology · 21 CFR 864.7340 · Class 2
Overview
| Product Code | GIL |
|---|---|
| Device Name | Plasma, Fibrinogen Control |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962407 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | Jul 29, 1996 | SESE |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Clinical Controls, Inc. | Aug 24, 1995 | SESE |
| K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | More Diagnostics | Aug 24, 1995 | SESE |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | Clinical Controls, Inc. | May 2, 1995 | SESE |
| K951012 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | Apr 17, 1995 | SESE |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | Sep 8, 1994 | SESE |
| K915462 | FIBRINOGEN CONTROL | Sigma Diagnostics, Inc. | Mar 4, 1992 | SESE |
| K833352 | GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL | Warner-Lambert Co. | Nov 3, 1983 | SESE |
Top Applicants
- Clinical Controls, Inc. — 3 clearances
- Behring Diagnostics, Inc. — 2 clearances
- Warner-Lambert Co. — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
- More Diagnostics — 1 clearance
