Identifiers
- 510(k) Number
- K780807 FDA 510(k)
- FDA Product Code
- JBD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7440 FDA 510(k)
- Regulation Number
- 864.7440 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HBF-QUIPLATE Methodology is a System, Analysis, Electrophoretic Hemoglobin device used for laboratory testing purposes. This methodology is designed for the analysis of hemoglobin electrophoresis, which is a laboratory technique used to separate and identify different types of hemoglobin in blood samples.
The device is supplied by Helena Laboratories and is classified as Class II with special controls. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device received FDA clearance on June 2, 1978, with the product code JBD and regulation number 864.7440.
Frequently asked questions
What is the HBF-QUIPLATE Methodology used for?
The HBF-QUIPLATE Methodology is a laboratory device designed for the analysis of hemoglobin electrophoresis, which separates and identifies different types of hemoglobin in blood samples for diagnostic purposes.
How is the HBF-QUIPLATE Methodology supplied?
The device is supplied by Helena Laboratories as a complete system for electrophoretic hemoglobin analysis. No information is provided regarding whether it is single-use or reusable, or if it requires sterile handling.
What is the regulatory status of the HBF-QUIPLATE Methodology?
The device received FDA clearance on June 2, 1978, as a Class II medical device with special controls. It has product code JBD and regulation number 864.7440, and was determined to be substantially equivalent to existing devices.
Are there different sizes or models of the HBF-QUIPLATE Methodology available?
No information is provided about different sizes or models of the HBF-QUIPLATE Methodology in the available device data. The description refers to it as a single system for hemoglobin electrophoresis analysis.
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: K780807 - HBF-QUIPLATE METHODOLOGY | FDA 510 (k), PDF K780807 - Hbf-quiplate Methodology, Hbf-quiplate Methodology 510 (k) K780807 - FDA.report, Procedures | Helena Laboratories - Innovations for Science & Clinical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K780807 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K780807 24 fields · synced Sep 22, 2026