Product code GFK— Hematology
TENS MAX
- Classification name
- Fibrinogen Determination Standards And Controls
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GFK
FDA has cleared device under product code GFK, all in 1983, filed by 1 applicant company. 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.
Top applicants under product code GFK
Recent clearances under product code GFK
Data sourced from openFDA. This site is unofficial and independent of the FDA.