Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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023
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Date of Entry 05/05/2010
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FR Recognition Number
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7-207
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Standard | |
CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition |
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Scope/AbstractThis document addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis. |
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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 |
21 CFR 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES |
21 CFR 864 HEMATOLOGY AND PATHOLOGY DEVICES |
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES |
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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 Contacts
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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. |