JFN — Atomic Absorption, Calcium Class II

FDA Device Classification

FDA product code JFN covers "Atomic Absorption, Calcium", a Class II medical device regulated under 21 CFR 862.1145. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JFN
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
K914510beckman instrumentsCALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALYNovember 19, 1991
K871903creative scientific technologyQUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)September 2, 1987
K770570beckman instrumentsCALCIUM/MAGNESIUM ANALYZERJune 8, 1977