Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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022
|
Date of Entry 09/08/2009
|
FR Recognition Number
|
13-29
|
Standard | |
CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
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Scope/AbstractThis document describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. |
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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 |
§862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
|
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 Groups (STG)
Software/Informatics (primary) |
InVitro Diagnostics |
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*These are provided as examples and others may be applicable. |