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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 023 FR Publication Date: 05/05/2010 

Part B: Supplementary Information

Recognition Number 7-209: CLSI POCT 05-A, performance metrics for continuous interstitial glucose monitoring. (InVitro Diagnostics)

Date of Standard: 2008. 
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:
Devices Affected:
Continuous Glucose Monitoring Systems
Processes Affected:
PMA, IDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Sensor, Glucose, Invasive Class 3 MDS
FDA Technical Contact:
 Patricia Bernhardt
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room 5654
  Silver Spring MD 20993
  301/796-6136
  email: patricia.bernhardt@fda.hhs.gov
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