JNM — Immunochemical, Transferrin Class II

FDA Device Classification

FDA product code JNM covers "Immunochemical, Transferrin", a Class II medical device regulated under 21 CFR 866.5880. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JNM
Device Class
Class II
Regulation Number
866.5880
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992188nichols institute diagnosticsNICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODecember 6, 1999
K981208ramco laboratoriesTFROctober 21, 1998
K970718r and d systemsQUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)May 27, 1997