LLG — Kit, Igg, Platelet Associated Class II

FDA Device Classification

FDA product code LLG covers "Kit, Igg, Platelet Associated", a Class II medical device regulated under 21 CFR 864.5425. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LLG
Device Class
Class II
Regulation Number
864.5425
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K841465general diagnosticsGENERAL DIAGNOSTICS PLATELET ANTIBODYJuly 2, 1984
K840257applied polytechnologyRAPID IMMUNO-ASSAY SYSApril 19, 1984