JIM — Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Class II

FDA Device Classification

FDA product code JIM covers "Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)", a Class II medical device regulated under 21 CFR 862.1340. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JIM
Device Class
Class II
Regulation Number
862.1340
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K902155hichem diagnosticsHI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)June 12, 1990
K790772boehringer mannheimCHEMTABJune 15, 1979