JFO — Fluorometric, Calcium Class II

FDA Device Classification

FDA product code JFO covers "Fluorometric, Calcium", a Class II medical device regulated under 21 CFR 862.1145. 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
JFO
Device Class
Class II
Regulation Number
862.1145
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K920974remelBACTIDROP ACRIDINE ORANGEJune 19, 1992