Product code CFE— Clinical Chemistry
LDH ISOENZYME REAGENT
- Classification name
- Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1445
- Advisory panel
- Clinical Chemistry
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code CFE
FDA has cleared devices under product code CFE between 1978 and 2010, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2002
- 1997
- 1994
- 1992
- 1991
- 1989
- 1987
- 1986
- 1985
- 1984
- 1983
- 1980
- 1979
- 1978
Top applicants under product code CFE
Recent clearances under product code CFE
- K100307 — GELSCAN, MODEL 1206
- K022455 — SPIFE LD-12 KIT, MODEL 3338
- K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
- K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
- K940224 — CARDIO REP LD
- K921455 — ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
- K905861 — ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
- K894081 — ROCHO ISOMUNE - LD
- K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078
- K874142 — TITAN GEL REP LDH-30 HV
- K874145 — TITAN GEL REP LDH-6 HV
- K874143 — TITAN GEL REP LDH-12 HV
- K873386 — TITAN GEL LDH REP SYSTEM
- K861750 — CK/LD BUFFER (CAT. NO. 5808)
- K850210 — ISOENZYME TEST LD-1
- K842669 — TITAN GEL ISO DOT LDH KIT
- K841433 — CORNING LACTATE DEHYDROPHORETIC ASSAY
- K832314 — CARDIZYME PLUS LD #65094/93
- K830872 — TITAN GEL LDH ISO-ENZYME CONTROL
- K802628 — PARAGON ELECTROPHORESIS LACTATE REAG.KIT
- K800568 — TRANSPHOR TM LD LACTATE DEHYDROGENASE
- K791373 — ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
- K791827 — LDH CLINI GEL KIT
- K791656 — ENZYME STABILIZING REAGENT (ESR)
- K791657 — LDH ISOENZYME REAGENT
- K790311 — LDH ISOENZYME REAGENT
- K781125 — LDH ISOENZYME REAGENT
- K780080 — LACTATE DEHYDROGENASE COLORIMETRIC SUB.
Data sourced from openFDA. This site is unofficial and independent of the FDA.