Roche Immunochemical LD Isoenzy Reagents
FDA 510(k) K791373 · Hoffmann-La Roche, Inc.
510(k) numberK791373
Submission
- Device name
- Roche Immunochemical LD Isoenzy Reagents
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- July 24, 1979
- Decision date
- October 26, 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
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 |
| 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 |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was Roche Immunochemical LD Isoenzy Reagents cleared by the FDA?
Roche Immunochemical LD Isoenzy Reagents (K791373) received a 510(k) decision of Substantially Equivalent on October 26, 1979, 94 days after the submission was received.
What is the product code of K791373?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.