CFH · Class II · 21 CFR 862.1440

FDA Product Code CFH: Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

Leading manufacturers include Helena Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Heraeus Kulzer, Inc..

13
Total
13
Cleared
54d
Avg days
1976
Since

FDA 510(k) Cleared Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase Devices (Product Code CFH)

13 devices
1–13 of 13
Cleared Oct 19, 1989
CLINISTAT LDH REAGENT TEST
K895138
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Oct 17, 1989
IQ LDH
K894578
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 85d
Cleared Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391
Helena Laboratories
Chemistry · 118d

About Product Code CFH - Regulatory Context