DeviceClearance

Product code LLG— Hematology

GENERAL DIAGNOSTICS PLATELET ANTIBODY

Classification name
Kit, Igg, Platelet Associated
Device class
Class 2
Regulation
21 CFR 864.5425
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

Market context for product code LLG

FDA has cleared 2 devices under product code LLG, all in 1984, 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.

Top applicants under product code LLG

Recent clearances under product code LLG

Data sourced from openFDA. This site is unofficial and independent of the FDA.