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Panels › Clinical Chemistry › Product code CFH · Class 2

Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

Regulation 862.1440

0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in CFH

Company510(k)sRecalls
Hycel, Inc.20
Anco Medical Reagents & Assoc.10
Arkray, Inc.10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Biorent Diagnostic, Inc.10
Careside, Inc.10
The Dow Chemical Co.10
Helena Laboratories10
Heraeus Kulzer, Inc.10
Sterling Diagnostics, Inc.10
Decided510(k)Device and applicantCode
Jun 6, 2005K050790SPOTCHEM II LDH TEST
Arkray, Inc.
CFH
Jul 3, 2002K020484CARESIDE LDH
Careside, Inc.
CFH
Oct 19, 1989K895138CLINISTAT LDH REAGENT TEST
Heraeus Kulzer, Inc.
CFH
Oct 17, 1989K894578IQ LDH
Bd Becton Dickinson Vacutainer Systems Preanalytic
CFH
Mar 16, 1988K880630LACTATE DEHYDROGENASE (LDH-L)
Tech-Co, Inc.
CFH
Feb 28, 1986K860349LACTATE DEHYDROGENASE (LDH) REAGENT SET
Sterling Diagnostics, Inc.
CFH
Oct 1, 1985K852391EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
Helena Laboratories
CFH
Aug 15, 1984K842452WAKO LDH CII TEST
Wako Chemicals USA, Inc.
CFH
Apr 14, 1982K820768COLORIMETRIC LDH REAGENT SET
Biorent Diagnostic, Inc.
CFH
Oct 9, 1981K812836LDH REAGENT SET
Anco Medical Reagents & Assoc.
CFH
Jan 26, 1979K782176HYCEL LDH-INT TEST
Hycel, Inc.
CFH
Aug 10, 1977K771343LDH-INT TEST
Hycel, Inc.
CFH
Jul 20, 1976K760009COLORIMETRIC DETERMINATION (LDH)
The Dow Chemical Co.
CFH

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