CFH · Class II · 21 CFR 862.1440

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

Leading manufacturers include Hycel, Inc., Anco Medical Reagents & Assoc. and Wako Chemicals USA, 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 Jun 06, 2005
SPOTCHEM II LDH TEST
K050790
Arkray, Inc.
Chemistry · 70d
Cleared Jul 03, 2002
CARESIDE LDH
K020484
Careside, Inc.
Chemistry · 140d
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
Cleared Oct 09, 1981
LDH REAGENT SET
K812836
Anco Medical Reagents & Assoc.
Chemistry
Cleared Jan 26, 1979
HYCEL LDH-INT TEST
K782176
Hycel, Inc.
Chemistry · 29d
Cleared Aug 10, 1977
LDH-INT TEST
K771343
Hycel, Inc.
Chemistry · 21d
Cleared Jul 20, 1976
COLORIMETRIC DETERMINATION (LDH)
K760009
The Dow Chemical Co.
Chemistry · 40d

About Product Code CFH - Regulatory Context