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rfa-300 rapid flow analyzer w computer
Alpkem
Summary: The RFA-300 Rapid Flow Analyzer by Alpkem is a medical device used for analyzing fluid samples rapidly. It is typically used by laboratory technicians and clinicians in diagnostic settings.
FDA Clearance Information
Pathway
510K
Number
K851542 ↗
Decision Date
May 10, 1985
Product Code
JJF
Device Class
Class 1
Evidence
0 studies
The RFA-300 Rapid Flow Analyzer was cleared through the FDA 510(k) pathway on May 10, 1985. Manufactured by Alpkem, it is classified as a Class I device under product code JJF.
What It Is
The RFA-300 Rapid Flow Analyzer is a laboratory device designed to quickly analyze fluid samples. It operates by using rapid flow techniques to deliver results efficiently. This device is particularly useful in settings where timely analysis of samples is critical, such as in hospital laboratories or research facilities.
Clinical Applications
The RFA-300 is commonly used in clinical laboratories for the analysis of various fluid samples, including blood and urine. It is particularly valuable in settings requiring rapid diagnostic results, such as emergency departments and intensive care units. Clinicians and laboratory technicians use this device to support patient diagnosis and treatment planning.
Indications for Use
The RFA-300 is indicated for use in the rapid analysis of fluid samples, which can include blood, urine, and other bodily fluids. It is suitable for patients requiring quick diagnostic results for effective clinical decision-making.
Practical Considerations
The RFA-300 is compatible with a variety of fluid sample types and is designed for ease of use in laboratory settings. It requires standard laboratory maintenance and calibration to ensure accurate results. Clinicians should be trained in its operation to maximize its diagnostic potential.
Frequently Asked Questions
What is the RFA-300 Rapid Flow Analyzer used for?
The RFA-300 is used for the rapid analysis of fluid samples in clinical laboratory settings.
What specialties typically use this device?
Laboratory technicians and clinicians in diagnostic and research laboratories commonly use this device.
What are the FDA-cleared indications?
The RFA-300 is cleared for the rapid analysis of fluid samples, aiding in quick diagnostic assessments.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.