Fluorometer

Device Code: 3019

Product Code(s): JZT

Device Classification Information

Device Type ID3019
Device NameFluorometer
Regulation DescriptionImmunofluorometer Equipment.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.4520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJZT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3019
DeviceFluorometer
Product CodeJZT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionImmunofluorometer Equipment.
CFR Regulation Number866.4520 [🔎]
TPLC Last Update: 2019-04-02 20:22:42

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