FDA 510(k) Applications for Medical Device Product Code "CFH"
(Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase)

FDA 510(k) Number Applicant Device Name Decision Date
K812836 ANCO MEDICAL REAGENTS & ASSOC. LDH REAGENT SET 10/09/1981
K050790 ARKRAY, INC. SPOTCHEM II LDH TEST 06/06/2005
K894578 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ LDH 10/17/1989
K820768 BIORENT DIAGNOSTIC, INC. COLORIMETRIC LDH REAGENT SET 04/14/1982
K020484 CARESIDE, INC. CARESIDE LDH 07/03/2002
K852391 HELENA LABORATORIES EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE 10/01/1985
K895138 HERAEUS KULZER, INC. CLINISTAT LDH REAGENT TEST 10/19/1989
K782176 HYCEL, INC. HYCEL LDH-INT TEST 01/26/1979
K771343 HYCEL, INC. LDH-INT TEST 08/10/1977
K860349 STERLING DIAGNOSTICS, INC. LACTATE DEHYDROGENASE (LDH) REAGENT SET 02/28/1986
K880630 TECH-CO, INC. LACTATE DEHYDROGENASE (LDH-L) 03/16/1988
K760009 THE DOW CHEMICAL CO. COLORIMETRIC DETERMINATION (LDH) 07/20/1976
K842452 WAKO CHEMICALS, USA, INC. WAKO LDH CII TEST 08/15/1984


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