LDH Isoenzyme Reagent

FDA 510(k) K790311 · Electrophoresis Corp.

Substantially Equivalent

510(k) numberK790311

Submission

Device name
LDH Isoenzyme Reagent
Applicant
Electrophoresis Corp.
Mchenry, IL, US
Received
February 13, 1979
Decision date
March 21, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1445
Specialty
Clinical Chemistry

Other 510(k)s with product code CFE

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K100307Gelscan, Model 1206CFE · Traditional Sebia08/31/2010SE
K022455Spife LD-12 Kit, Model 3338CFE · Traditional Helena Laboratories10/01/2002SE
K020467Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452CFE · Traditional Helena Laboratories03/29/2002SE
K970477Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh KitCFE · Traditional Sebia03/10/1997SE
K940224Cardio Rep LDCFE · Traditional Helena Laboratories08/17/1994SE
K921455Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) MethodCFE · Traditional E.I. Dupont DE Nemours & Co., Inc.04/29/1992SE
K905861Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) MethCFE · Traditional E.I. Dupont DE Nemours & Co., Inc.02/06/1991SE
K894081Rocho Isomune - LDCFE · Traditional Roche Diagnostic Systems, Inc.08/31/1989SE
K892818Rep(Tm) LD-2 Stat Kit, Cat. No. 3078CFE · Traditional Helena Laboratories06/20/1989SE
K874145Titan Gel Rep LDH-6 HVCFE · Traditional Helena Laboratories11/24/1987SE

More from Helena Laboratories

510(k)DeviceDecision
K802395Special Procedure Aqarose FilmJJN · Traditional 11/26/1980SE
K790309CPK Isoenzyme SubstrateJHY · Traditional 04/04/1979SE
K790310Hemoglobin ControlsGGM · Traditional 03/21/1979SE

Questions and answers

When was LDH Isoenzyme Reagent cleared by the FDA?

LDH Isoenzyme Reagent (K790311) received a 510(k) decision of Substantially Equivalent on March 21, 1979, 36 days after the submission was received.

What is the product code of K790311?

The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.