Product code LGL— Hematology
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
- Classification name
- Assay, Bart'S, Hemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LGL
FDA has cleared devices under product code LGL, all in 1981, 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 LGL
Recent clearances under product code LGL
Data sourced from openFDA. This site is unofficial and independent of the FDA.