Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) Meth
FDA 510(k) K905861 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK905861
Submission
- Device name
- Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) Meth
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- December 31, 1990
- Decision date
- February 6, 1991
- 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
Other 510(k)s with product code CFE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K874142 | Titan Gel Rep LDH-30 HVCFE · Traditional | Helena Laboratories | 11/24/1987SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional | 07/24/1996SE |
| K953725 | Cronex Radiation Therapy Verification CassetteIXA · Traditional | 09/06/1995SE |
| K953724 | Cronex Radiation Therapy CassetteIXA · Traditional | 09/06/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
| K950137 | Urine Barbiturates Screen Flex(Tm) Reagent CartridgeDIS · Traditional | 04/13/1995SE |
| K950181 | Urine Cannabinoids Screen Flex(Tm) Reagent CartridgeLDJ · Traditional | 04/05/1995SE |
| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | 03/30/1995SE |
| K950427 | Urine Benzodiazepines Screen Flex Teagent CartridgeJXM · Traditional | 03/21/1995SE |
| K950182 | Urine Methadone Screen Flex(Tm) Reagent CartridgeDIW · Traditional | 03/21/1995SE |
Questions and answers
When was Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) Meth cleared by the FDA?
Aca(R) Lactic Dehydrogenase Isoenzyme 1 (LD1) Meth (K905861) received a 510(k) decision of Substantially Equivalent on February 6, 1991, 37 days after the submission was received.
What is the product code of K905861?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.