Product code GIG— Hematology
HBM HEMOGLOBINOMETER
- Classification name
- Hemoglobinometer
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GIG
FDA has cleared devices under product code GIG between 1977 and 1997, filed by 3 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
- 1997
- 1994
- 1977
Top applicants under product code GIG
Recent clearances under product code GIG
Data sourced from openFDA. This site is unofficial and independent of the FDA.