Product code GIA— Hematology
FAST'N'FLAMMATORY KIT
- Classification name
- Test, Leukocyte Peroxidase
- Device class
- Class 1
- Regulation
- 21 CFR 864.7675
- Advisory panel
- Hematology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GIA
FDA has cleared devices under product code GIA between 1981 and 1994, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1985
- 1981
Top applicants under product code GIA
Recent clearances under product code GIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.