JII — Atomic Absorption, Lithium Class II

FDA Device Classification

FDA product code JII covers "Atomic Absorption, Lithium", a Class II medical device regulated under 21 CFR 862.3560. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JII
Device Class
Class II
Regulation Number
862.3560
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K082001diazyme laboratoriesDIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDecember 5, 2008
K033360general atomicsDIAZYME LITHIUM ENZYMATIC ASSAY KITDecember 23, 2003
K912244in wha pharmaceutical coUROTEST GPHNovember 22, 1991