JKG — L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase Class I

FDA Device Classification

FDA product code JKG covers "L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase", a Class I medical device regulated under 21 CFR 862.1420. 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
JKG
Device Class
Class I
Regulation Number
862.1420
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K770519sigma chemicalREAGENT SYSTEM 153-UVJune 3, 1977