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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 13-12: CLSI AUTO4-A, laboratory automation: systems operational requirements, characteristics, and information elements; approved standard. (Software/Informatics)

Date of Standard: 2001. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Lab Information Systems, Auto Analysis
Processes Affected:
510(K), PMA, PDP
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
FDA Technical Contact:
 James Callaghan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5658
  Silver Spring MD 20993
  301/796-6137
  email: james.callaghan@fda.hhs.gov
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