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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 13-27: CLSI AUTO11-A, it security of in vitro diagnostic instruments and software systems; approved standard. (Software/Informatics)

Date of Standard: 2006. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Lab Information Systems, Auto Analysis
Processes Affected:
510(k), PMA, PDP
Type of Standard:
 Horizontal, International
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 Contacts:
 Douglass O. Wood
  FDA/CDRH/OSB
  1350 Piccard Drive, HFZ-520
  Rockville MD 20850
  240/276-3425
  email: doug.wood@fda.hhs.gov
 Eugene Reilly
  FDA/CDRH/OIVD
  2098 Gaither Road, HFZ-440
  Rockvile MD 20850
  240/276-0703
  email: eugene.reilly@fda.hhs.gov
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