FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K802628 |
BECKMAN INSTRUMENTS, INC. |
PARAGON ELECTROPHORESIS LACTATE REAG.KIT |
12/11/1980 |
K791827 |
CLINICAL SCIENCES, INC. |
LDH CLINI GEL KIT |
10/01/1979 |
K841433 |
CORNING MEDICAL & SCIENTIFIC |
CORNING LACTATE DEHYDROPHORETIC ASSAY |
05/16/1984 |
K780080 |
CORNING MEDICAL & SCIENTIFIC |
LACTATE DEHYDROGENASE COLORIMETRIC SUB. |
02/07/1978 |
K800568 |
CORNING MEDICAL & SCIENTIFIC |
TRANSPHOR TM LD LACTATE DEHYDROGENASE |
04/04/1980 |
K921455 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD |
04/29/1992 |
K905861 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH |
02/06/1991 |
K790311 |
ELECTROPHORESIS CORP. |
LDH ISOENZYME REAGENT |
03/21/1979 |
K791656 |
ELECTROPHORESIS CORP. OF AMERICA |
ENZYME STABILIZING REAGENT (ESR) |
09/17/1979 |
K791657 |
ELECTROPHORESIS CORP. OF AMERICA |
LDH ISOENZYME REAGENT |
09/17/1979 |
K781125 |
ELECTROPHORESIS CORP. OF AMERICA |
LDH ISOENZYME REAGENT |
08/10/1978 |
K832314 |
EM INDUSTRIES, INC. |
CARDIZYME PLUS LD #65094/93 |
09/01/1983 |
K940224 |
HELENA LABORATORIES |
CARDIO REP LD |
08/17/1994 |
K861750 |
HELENA LABORATORIES |
CK/LD BUFFER (CAT. NO. 5808) |
05/29/1986 |
K892818 |
HELENA LABORATORIES |
REP(TM) LD-2 STAT KIT, CAT. NO. 3078 |
06/20/1989 |
K020467 |
HELENA LABORATORIES |
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 |
03/29/2002 |
K022455 |
HELENA LABORATORIES |
SPIFE LD-12 KIT, MODEL 3338 |
10/01/2002 |
K842669 |
HELENA LABORATORIES |
TITAN GEL ISO DOT LDH KIT |
11/09/1984 |
K830872 |
HELENA LABORATORIES |
TITAN GEL LDH ISO-ENZYME CONTROL |
04/12/1983 |
K873386 |
HELENA LABORATORIES |
TITAN GEL LDH REP SYSTEM |
10/20/1987 |
K874143 |
HELENA LABORATORIES |
TITAN GEL REP LDH-12 HV |
11/23/1987 |
K874142 |
HELENA LABORATORIES |
TITAN GEL REP LDH-30 HV |
11/24/1987 |
K874145 |
HELENA LABORATORIES |
TITAN GEL REP LDH-6 HV |
11/24/1987 |
K791373 |
HOFFMANN-LA ROCHE, INC. |
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS |
10/26/1979 |
K894081 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ROCHO ISOMUNE - LD |
08/31/1989 |
K850210 |
SCLAVO, INC. |
ISOENZYME TEST LD-1 |
03/29/1985 |
K100307 |
SEBIA |
GELSCAN, MODEL 1206 |
08/31/2010 |
K970477 |
SEBIA |
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT |
03/10/1997 |