Rep Spe Hi-Res System No. 3176, 3177, 3178
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K892424 FDA 510(k)
- FDA Product Code
- CFF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 is an immunoelectrophoretic device for immunoglobulins (G, A, M), as defined by its device name and product code CFF. It is a traditional 510(k) cleared device classified as Class II, substantially equivalent to a predicate device, and intended for use in immunology testing.
The system was cleared by the FDA on June 9, 1989, under K892424, and is manufactured by Helena Laboratories in Beaumont, Texas. It is supplied as a reusable system for laboratory use, with no indication of sterility, single-use designation, MRI safety, or specific storage conditions provided in the data. Authorisations include FDA 510(k) clearance, and it is registered under the specified FEI and registration numbers.
Frequently asked questions
What is the REP SPE HI-RES System 3176-3178 used for?
The REP SPE HI-RES System 3176-3178 is an immunoelectrophoretic device intended for use in immunology testing to detect and analyze immunoglobulins G, A, and M, based on its device name and product code CFF.
Is the REP SPE HI-RES System 3176-3178 supplied as a single-use or reusable system?
The system is supplied as a reusable system for laboratory use, as explicitly stated in the device description, with no indication of single-use designation or sterility.
What regulatory pathway was used for the REP SPE HI-RES System 3176-3178?
The device received traditional 510(k) clearance from the FDA on June 9, 1989, under K892424, and is classified as a Class II device substantially equivalent to a predicate.
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. Sources consulted: K892424 FDA 510(k) - REP SPE HI-RES SYSTEM NO. 3176, REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424 ... - fda ..., REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424 ... - fda ..., K923658 - REP IMMUNOFIX | FDA 510 (k) | Helena Laboratories, FDA Product Code CFF - Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K892424 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K892424 24 fields · synced Sep 24, 2026