JGX — Turbidimetric Method, Triglycerides Class I

FDA Device Classification

FDA product code JGX covers "Turbidimetric Method, Triglycerides", a Class I medical device regulated under 21 CFR 862.1705. 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
JGX
Device Class
Class I
Regulation Number
862.1705
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K831874sterling biochemicalLIPASE REAGENT SETAugust 12, 1983