Kit, Test, Olfactory

Device Code: 1632

Product Code(s): NRK

Definition: The Home Test For Loss Of The Sense Of Smell Is Packaged In A Small Carton Which Contains (1) An Instruction Book, (2) A Booklet Containing Twelve Micorencapsulated Smell Strips, Each On A Separate Page, With Instructions For Scoring The Test And An

Device Classification Information

Device Type ID1632
Device NameKit, Test, Olfactory
Regulation DescriptionOlfactory Test Device.
Regulation Medical SpecialtyEar Nose & Throat
Review PanelEar Nose & Throat
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Ear, Nose, And Throat Devices Branch (ENTB)
Submission Type510(K) Exempt
CFR Regulation Number874.1600 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNRK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1632
DeviceKit, Test, Olfactory
Product CodeNRK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOlfactory Test Device.
CFR Regulation Number874.1600 [🔎]
TPLC Last Update: 2019-04-02 19:56:51

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