JGW — Fluorometric Method, Triglycerides Class I

FDA Device Classification

FDA product code JGW covers "Fluorometric Method, Triglycerides", a Class I medical device regulated under 21 CFR 862.1705. 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
JGW
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
K872912sigma chemicalTRIGLYCERIDE (UV) REAGENTAugust 17, 1987
K852556abbott laboratoriesTDX REA TRIGLYCERIDESJuly 22, 1985
K780439boehringer mannheimPRECIMAT GLYCEROLApril 18, 1978