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 Type ID | 1632 |
Device Name | Kit, Test, Olfactory |
Regulation Description | Olfactory Test Device. |
Regulation Medical Specialty | Ear Nose & Throat |
Review Panel | Ear 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 Type | 510(K) Exempt |
CFR Regulation Number | 874.1600 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NRK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1632 |
Device | Kit, Test, Olfactory |
Product Code | NRK |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Olfactory Test Device. |
CFR Regulation Number | 874.1600 [🔎] |