Methenamine Silver

Device Code: 4780

Product Code(s): HYZ

Device Classification Information

Device Type ID4780
Device NameMethenamine Silver
Regulation DescriptionDye And Chemical Solution Stains.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.1850 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHYZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4780
DeviceMethenamine Silver
Product CodeHYZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDye And Chemical Solution Stains.
CFR Regulation Number864.1850 [🔎]
TPLC Last Update: 2019-04-02 20:55:30

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