Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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020
|
Date of Entry 09/09/2008
|
FR Recognition Number
|
13-13
|
Standard | |
CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard |
|
Scope/AbstractThis document provides standards for the development of an electromechanical interface between instruments and specimen processing and handling devices used in automated laboratory testing procedures. |
|
Extent of Recognition
|
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. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |