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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 021 Publication Date: 03/18/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-173: CLSI C44-A, Harmonization of Glycohemoglobin Measurements. (InVitro Diagnostics)

Date of Standard: 2002. 
Address of Standards 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:
Chemistry, Hematology
Processes Affected:
510(k), PMA, IDE, HDE
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.7470 Assay, Glycosylated Hemoglobin Class 2 LCP
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Yung Chan
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  Email: yung.chan@fda.hhs.gov
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