LDH Isoenzyme Reagent
FDA 510(k) K791657 · Electrophoresis Corp. of America
510(k) numberK791657
Submission
- Device name
- LDH Isoenzyme Reagent
- Applicant
- Electrophoresis Corp. of America
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- September 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K100307 | Gelscan, Model 1206CFE · Traditional | Sebia | 08/31/2010SE |
| K022455 | Spife LD-12 Kit, Model 3338CFE · Traditional | Helena Laboratories | 10/01/2002SE |
| K020467 | Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452CFE · Traditional | Helena Laboratories | 03/29/2002SE |
| K970477 | Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh KitCFE · Traditional | Sebia | 03/10/1997SE |
| K940224 | Cardio Rep LDCFE · Traditional | Helena Laboratories | 08/17/1994SE |
| K921455 | Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) MethodCFE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/29/1992SE |
| K905861 | Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) MethCFE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/06/1991SE |
| K894081 | Rocho Isomune - LDCFE · Traditional | Roche Diagnostic Systems, Inc. | 08/31/1989SE |
| K892818 | Rep(Tm) LD-2 Stat Kit, Cat. No. 3078CFE · Traditional | Helena Laboratories | 06/20/1989SE |
| K874145 | Titan Gel Rep LDH-6 HVCFE · Traditional | Helena Laboratories | 11/24/1987SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K802396 | General Procedure Agarose FilmJJN · Traditional | 11/26/1980SE |
| K792553 | Agarose Barbital-Edta BufferJJN · Traditional | 01/29/1980SE |
| K792551 | Alkaline Phosphatase ReagentCJH · Traditional | 01/29/1980SE |
| K792548 | Alkaline Phosphatase MarkerCIN · Traditional | 01/29/1980SE |
| K792547 | Agarose Barbital BufferJJN · Traditional | 01/29/1980SE |
| K792574 | Mopso BufferJCC · Traditional | 01/21/1980SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | 01/16/1980SE |
| K792552 | Amido Black 10B StainHZZ · Traditional | 12/18/1979SE |
| K792549 | Fat Red 7B Stain SetHYD · Traditional | 12/18/1979SE |
| K791656 | Enzyme Stabilizing Reagent (Esr)CFE · Traditional | 09/17/1979SE |
Questions and answers
When was LDH Isoenzyme Reagent cleared by the FDA?
LDH Isoenzyme Reagent (K791657) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 27 days after the submission was received.
What is the product code of K791657?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.