Product code GIQ— Hematology
HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
- Classification name
- Hemoglobin S
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GIQ
FDA has cleared devices under product code GIQ between 1988 and 1996, 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
- 1996
- 1995
- 1988
Top applicants under product code GIQ
Recent clearances under product code GIQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.