Methyl Green

Device Code: 4781

Product Code(s): HZA

Device Classification Information

Device Type ID4781
Device NameMethyl Green
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 CodeHZA
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4781
DeviceMethyl Green
Product CodeHZA
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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