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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 7-150: CLSI H43-A2, clinical flow cytometry analysis of neoplastic hematolymphoid cells; approved guideline - second edition. (InVitro Diagnostics)

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:
Devices That Utilize Immunofluorescence-Based Flow Cytometry Methodology for The Immunophenotypic Analysis Of Leukemic And Lymphoma Cells
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
§864.5220 Counter, Differential Cell Class 2 GKZ
Relevant Guidance:
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA
FDA Technical Contact:
 Kevin Maher, Ph.D.
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room 4246
  Silver Spring MD 20993
  301/796-6879
  email: kevin.maher@fda.hhs.gov
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