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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 7-142: CLSI GP43-A4 (Formerly H11-A4), procedures for the collection of arterial blood specimens; approved standard -- fourth 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 Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
BLOOD COLLECTION DEVICES
Processes Affected:
510(k), PMA, IDE, HDE
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1675 Tray, Blood Collection Class 2 GJE
§862.1675 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
FDA Technical Contact:
 Yung Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  email: yung.chan@fda.hhs.gov
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