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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 7-167: CLSI GP23-A, nongynecologic cytologic specimens: collection and cytopreparatory techniques; approved guideline. (InVitro Diagnostics)

Date of Standard: 1999. 
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:
Cytocentrifuge; Microscopes and accessories; Slides, Microscope
Processes Affected:
Collection and preparation of fine needle aspiration specimens
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.1850 Stain, Ponceau Class 1 HZO
§864.3010 Slides, Microscope Class 1 KEW
§864.3300 Cytocentrifuge Class 1 IFB
§864.3600 Light, Microscope Class 1 IBJ
§864.3800 Stainer, Tissue, Automated Class 1 KEY
FDA Technical Contact:
 Shyam Kalavar
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5568
  Silver Spring MD 20993
  301/796-6807
  email: shyam.kalavar@fda.hhs.gov
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