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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 7-135: CLSI H44-A2, methods for reticulocyte counting (automated blood cell counters, flow cytometry, and supravital dyes); approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2004. 
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)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
Methods for reticulocyte counting
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
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:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance

Class II: Special Controls Guidance Document: Premarket Notification for Automated Differential Cell Counters for Immature or Abnormal Blood Cells
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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