Strip, Schirmer

Device Code: 4326

Product Code(s): KYD

Device Classification Information

Device Type ID4326
Device NameStrip, Schirmer
Regulation DescriptionSchirmer Strip.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.1800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKYD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4326
DeviceStrip, Schirmer
Product CodeKYD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSchirmer Strip.
CFR Regulation Number886.1800 [🔎]
TPLC Last Update: 2019-04-02 20:47:01

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