CFH · Class II · 21 CFR 862.1440

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

Leading manufacturers include Wako Chemicals USA, Inc., Helena Laboratories and Sterling Diagnostics, 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 Mar 16, 1988
LACTATE DEHYDROGENASE (LDH-L)
K880630
Tech-Co, Inc.
Chemistry · 29d
Cleared Feb 28, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349
Sterling Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391
Helena Laboratories
Chemistry · 118d
Cleared Aug 15, 1984
WAKO LDH CII TEST
K842452
Wako Chemicals USA, Inc.
Chemistry · 54d

About Product Code CFH - Regulatory Context