Product code LBL— Ear, Nose, Throat
J&S HDL CHOLESTEROL PRECIPITATING REAGENT
- Classification name
- Tube, Tympanostomy, Porous Polyethylene
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LBL
FDA has cleared device under product code LBL, all in 1990, 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 LBL
Recent clearances under product code LBL
Data sourced from openFDA. This site is unofficial and independent of the FDA.