Cuvette, Thermostated

Device Code: 576

Product Code(s): JRI

Device Classification Information

Device Type ID576
Device NameCuvette, Thermostated
Regulation DescriptionGeneral Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.2050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJRI
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID576
DeviceCuvette, Thermostated
Product CodeJRI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
CFR Regulation Number862.2050 [🔎]
TPLC Last Update: 2019-04-02 19:36:45

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