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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 7-71: CLSI H15-A3, reference and selected procedures for the quantitative determination of hemoglobin in blood; approved standard - third edition. (InVitro Diagnostics)

Date of Standard: 2000. 
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:
Devices that measure hemoglobin in blood
Processes Affected:
510(K), PMA, IDE, PDP
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.5200 Counter, Cell, Automated (Particle Counter) Class 2 GKL
§864.5620 System, Hemoglobin, Automated Class 2 GKR
§864.8165 Calibrator For Hemoglobin And Hematocrit Measurement Class 2 KRZ
FDA Technical Contact:
 Lan Nguyen
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4228
  Silver Spring MD 20993
  301/796-6178
  email: lan.nguyen@fda.hhs.gov
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