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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 13-10: CLSI AUTO1-A, laboratory automation: specimen container/specimen carrier; approved standard. (Software/Informatics)

Date of Standard: 2000. 
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 DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
All containers, Specimen transport
Processes Affected:
510(k), PMA, PDP
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.3250 Container, Specimen Mailer And Storage, Sterile Class 1 KDT
§864.3250 Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Class 1 KDW
§864.3250 Container, Specimen, Sterile Class 1 FMH
FDA Technical Contact:
 Beth Stephen
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5626
  Silver Spring MD 20993
  301/796-6222
  email: beth.stephen@fda.hhs.gov
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