Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
The Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) is a clinical laboratory device used to purify water to the quality required for reagent preparation and instrument use in clinical chemistry testing, employing one or more purification methods including absorption, ion exchange deionization, membrane filtration, or reverse osmosis. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRS and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JRS
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.