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2006P-0271: Amend Practice of Assessing the Performance of Medical Devices for Determining in Vitro Susceptibility of Bacteria or Fungi to Included CLSI

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
CP1 06/26/2006 06/26/2006 Private Industry Clinical and Laboratory Standards Institute       Table of Contents  
Signature: Robert Habig, PhD
ACK1 06/27/2006 06/27/2006 Federal Government FDA/DDM to Clinical and Laboratory Standards Institute       pdf  
Signature: Jennie C. Butler
C1 08/01/2006 07/28/2006 Association Society of Infectious Diseases Pharmacists pdf
Signature: Thomas C Hardin, PharmD, MBA, FCC
EC1 09/15/2006 09/14/2006 Health Care Association
Infectious Diseases Society of America htm
Signature: Blaser, Martin
EC2 09/19/2006 09/18/2006 Health Care Association
Infectious Diseases Society of America htm
Signature: Blaser, Martin J.
LET1 01/10/2007 01/10/2007 Federal Government
FDA to Clinical and Laboratory Standards Institute (CLSI)
pdf
Signature: Murray M. Lumpkin, M.D.
C2 01/11/2007 01/05/2007 Health Care Association
American Society for Microbiology (ASM) pdf
Signature: Ruth L. Berkelman, M.D. and Joseph
PAV1 03/06/2007 03/06/2007 Federal Government
FDA to Clinical and Laboratory Standards Institute (CLSI)
pdf and denied in part
Signature: Murray M Lumpkin MD

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Page last updated: March 20, 2007