Identifiers
- 510(k) Number
- K022455 FDA 510(k)
- FDA Product Code
- CFE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1445 FDA 510(k)
- Regulation Number
- 862.1445 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SPIFE LD-12 Kit, Model 3338 is an electrophoretic device for lactate dehydrogenase isoenzymes, used in clinical chemistry applications. It is designed to separate and analyze lactate dehydrogenase isoenzymes via electrophoresis.
The device is supplied as a kit and is intended for use in clinical laboratory settings. It has received FDA 510(k) clearance under K022455 and is classified as a Class II medical device with product code CFE. The device is not MRI safety information provided in the data, and no details on sterility, single-use or reusable status, sizes, or storage are specified in the supplied specifications.
Frequently asked questions
What is the SPIFE LD-12 Kit, Model 3338 used for?
The SPIFE LD-12 Kit, Model 3338 is used to separate and analyze lactate dehydrogenase isoenzymes via electrophoresis in clinical chemistry applications, aiding in the assessment of tissue damage or disease states based on LDH isoenzyme patterns.
How is the SPIFE LD-12 Kit, Model 3338 supplied and intended for use?
The device is supplied as a kit and is intended for use in clinical laboratory settings, where it performs electrophoretic separation of lactate dehydrogenase isoenzymes from patient samples for diagnostic evaluation.
What regulatory pathway was used for the SPIFE LD-12 Kit, Model 3338?
The SPIFE LD-12 Kit, Model 3338 received FDA 510(k) clearance under submission K022455, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code CFE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022455 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K022455 24 fields · synced Sep 23, 2026