Product code GIL— Hematology
N/T PROTEIN CONTROL PY
- Classification name
- Plasma, Fibrinogen Control
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code GIL
FDA has cleared devices under product code GIL between 1983 and 1996, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1996
- 1995
- 1994
- 1992
- 1983
Top applicants under product code GIL
Recent clearances under product code GIL
- K962407 — N/T PROTEIN CONTROL PY
- K946193 — FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
- K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
- K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
- K951012 — N/T PROTEIN CONTROL PY
- K934741 — LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
- K915462 — FIBRINOGEN CONTROL
- K833352 — GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.