JOC — Colorimetric, Xylose Class I

FDA Device Classification

FDA product code JOC covers "Colorimetric, Xylose", a Class I medical device regulated under 21 CFR 862.1820. 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
JOC
Device Class
Class I
Regulation Number
862.1820
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K991156great smokies diagnostic laboratoryGREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEMMay 28, 1999