MPG — Urinary Carbohydrate Analysis Kit Class I

FDA Device Classification

FDA product code MPG covers "Urinary Carbohydrate Analysis Kit", a Class I medical device regulated under 21 CFR 862.1505. 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
MPG
Device Class
Class I
Regulation Number
862.1505
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K945519pharmaquestFACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANNovember 3, 1995