Product code GFT— Hematology
HEPARIN ASSAY CARTRIDGES AND CONTROLS
- Classification name
- Protamine Sulphate
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GFT
FDA has cleared devices under product code GFT between 1991 and 1995, filed by 2 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
- 1995
- 1991
Top applicants under product code GFT
Recent clearances under product code GFT
Data sourced from openFDA. This site is unofficial and independent of the FDA.