Vapor Pressure, Osmolality Of Serum & Urine

Device Code: 527

Product Code(s): JNA

Device Classification Information

Device Type ID527
Device NameVapor Pressure, Osmolality Of Serum & Urine
Regulation DescriptionOsmolality Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.1540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJNA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID527
DeviceVapor Pressure, Osmolality Of Serum & Urine
Product CodeJNA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOsmolality Test System.
CFR Regulation Number862.1540 [🔎]
TPLC Last Update: 2019-04-02 19:36:00

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