JNF — Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen Class I

FDA Device Classification

FDA product code JNF covers "Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen", a Class I medical device regulated under 21 CFR 862.1590. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
JNF
Device Class
Class I
Regulation Number
862.1590
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K961984trace americaPORPHOBILINOGEN (PBG)December 10, 1996