Atlas FDA

CFE

28 FDA 510(k) clearances · Product code

42 daysmedian time to decision
122 days90th percentile
28clearances measured

FDA profile

Official device name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1445
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GELSCAN, MODEL 1206 (K100307)Sebia2010-08-31
SPIFE LD-12 KIT, MODEL 3338 (K022455)Helena Laboratories2002-10-01
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (K020467)Helena Laboratories2002-03-29
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477)Sebia1997-03-10
CARDIO REP LD (K940224)Helena Laboratories1994-08-17
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (K921455)E.I. Dupont DE Nemours & Co., Inc.1992-04-29
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (K905861)E.I. Dupont DE Nemours & Co., Inc.1991-02-06
ROCHO ISOMUNE - LD (K894081)Roche Diagnostic Systems, Inc.1989-08-31
REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (K892818)Helena Laboratories1989-06-20
TITAN GEL REP LDH-30 HV (K874142)Helena Laboratories1987-11-24
TITAN GEL REP LDH-6 HV (K874145)Helena Laboratories1987-11-24
TITAN GEL REP LDH-12 HV (K874143)Helena Laboratories1987-11-23
TITAN GEL LDH REP SYSTEM (K873386)Helena Laboratories1987-10-20
CK/LD BUFFER (CAT. NO. 5808) (K861750)Helena Laboratories1986-05-29
ISOENZYME TEST LD-1 (K850210)Sclavo, Inc.1985-03-29
TITAN GEL ISO DOT LDH KIT (K842669)Helena Laboratories1984-11-09
CORNING LACTATE DEHYDROPHORETIC ASSAY (K841433)Corning Medical & Scientific1984-05-16
CARDIZYME PLUS LD #65094/93 (K832314)Em Industries, Inc.1983-09-01
TITAN GEL LDH ISO-ENZYME CONTROL (K830872)Helena Laboratories1983-04-12
PARAGON ELECTROPHORESIS LACTATE REAG.KIT (K802628)Beckman Instruments, Inc.1980-12-11
TRANSPHOR TM LD LACTATE DEHYDROGENASE (K800568)Corning Medical & Scientific1980-04-04
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS (K791373)Hoffmann-La Roche, Inc.1979-10-26
LDH CLINI GEL KIT (K791827)Clinical Sciences, Inc.1979-10-01
ENZYME STABILIZING REAGENT (ESR) (K791656)Electrophoresis Corp. of America1979-09-17
LDH ISOENZYME REAGENT (K791657)Electrophoresis Corp. of America1979-09-17
LDH ISOENZYME REAGENT (K790311)Electrophoresis Corp.1979-03-21
LDH ISOENZYME REAGENT (K781125)Electrophoresis Corp. of America1978-08-10
LACTATE DEHYDROGENASE COLORIMETRIC SUB. (K780080)Corning Medical & Scientific1978-02-07

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Every clearance here is in the API, with alerts when new ones post.