Product code GHQ— Hematology
CALTAG FETAL HEMOGLOBIN TEST
- Classification name
- Stain, Fetal Hemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7455
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GHQ
FDA has cleared devices under product code GHQ between 1989 and 1999, 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
- 1999
- 1989
Top applicants under product code GHQ
Recent clearances under product code GHQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.