JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
JGF
Device Class
Class II
Regulation Number
862.1445
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K981338abbott laboratoriesLD-1May 18, 1998
K925188em diagnostic systemsABBOTT QUICKSTART LD-1, MODIFICATIONFebruary 5, 1993
K914261em diagnostic systemsABBOTT QUICKSTART LD-1,#5A30October 21, 1991
K890996trace scientificLD1 ISOENZYME REAGENT KITMay 5, 1989
K871240abbott laboratoriesABBOTT A-GENT LD-1 ISOZYME REAGENTMay 13, 1987
K860367alpkemMAGNESIUM (SUBSTRATE, ENZYME, REAGENT)April 11, 1986