Hematoxylin Mayer's

Device Code: 4772

Product Code(s): HYL

Device Classification Information

Device Type ID4772
Device NameHematoxylin Mayer's
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 CodeHYL
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4772
DeviceHematoxylin Mayer's
Product CodeHYL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDye And Chemical Solution Stains.
CFR Regulation Number864.1850 [🔎]
TPLC Last Update: 2019-04-02 20:55:23

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