Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452
FDA 510(k) K020467 · Helena Laboratories
510(k) numberK020467
Submission
- Device name
- Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 12, 2002
- Decision date
- March 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
| K874142 | Titan Gel Rep LDH-30 HVCFE · Traditional | Helena Laboratories | 11/24/1987SE |
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Questions and answers
When was Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452 cleared by the FDA?
Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452 (K020467) received a 510(k) decision of Substantially Equivalent on March 29, 2002, 45 days after the submission was received.
What is the product code of K020467?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.