Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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021
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Date of Entry 03/18/2009
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FR Recognition Number
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7-71
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Standard | |
CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
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Scope/AbstractThis document describes the principle, materials, and procedure for reference and standardized hemoglobin determinations. It includes specifications for secondary hemiglobincyanide (HiCN) standards. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§864.5620 |
System, Hemoglobin, Automated |
Class 2 |
GKR |
§864.5200 |
Counter, Cell, Automated (Particle Counter) |
Class 2 |
GKL |
§864.8165 |
Calibrator For Hemoglobin And Hematocrit Measurement |
Class 2 |
KRZ |
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |