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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 7-166: CLSI GP20-A2, fine needle aspiration biopsy (fnab) techniques; approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2003. 
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; Tissue processing equipment
Processes Affected:
Collection and preparation of fine needle aspiration specimens, 510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, 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 Cassettes, Tissue Class 1 IDZ
§864.3010 Microtome, Accessories Class 1 IDL
§864.3010 Microtome, Rotary Class 1 IDO
§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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